MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-06-03 for TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK manufactured by Tambrands Manufacturing, Inc..
[75781094]
Lot # or product were not provided by the reporter.
Patient Sequence No: 1, Text Type: N, H10
[75781095]
Toxic shock syndrome, vomiting, high fever [pyrexia]. Fell unconscious [loss of consciousness] fell into a coma. Case description: the mother of a (b)(6) female reported that her daughter used tampax tampon, version/absorbency/scent unknown beginning on an unspecified date, and she had toxic shock twice; once in (b)(6) 2014, and once in (b)(6) 2014. She now has to live with having toxic shock syndrome. No further information was provided. On 01/23/2014, consumer relations follow-up phone call with the mother. The mother reported that her daughter first experienced toxic shock syndrome on (b)(6) 2014, and was hospitalized for 1 week in intensive care. The second episode occurred on (b)(6) 2014, she started vomiting, had a high fever, and fell unconscious and into a coma. She was treated with a high dose of intravenous adrenaline, very strong antibiotics, and penicillin. She is better physically, but she is very psychologically affected and will be seeing a psychiatrist. She stated her daughter lives with the syndrome every day. She had used tampax since her first period, but now she is not permitted to use tampons for the rest of her life. The case outcome was improved. No further information was provided. On 01/26/2015, follow-up phone call with general practitioner: the physician reported that she is awaiting the final opinion of specialists regarding this case. The hospital where the consumer first sought treatment had asked for an additional opinion from another hospital. The consumer had also asked for the opinion of someone in another location. The physician reported that the consumer's daughter had likely used tampons a second time. It was not confirmed whether the tampon was the cause. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[77879005]
Patient Sequence No: 1, Text Type: N, H10
[78157634]
Lot number or product was not provided by the reporter.
Patient Sequence No: 1, Text Type: N, H10
[78157635]
Toxic shock syndrome [toxic shock syndrome]. Vomiting [vomiting]. High fever [pyrexia]. Fell unconscious [loss of consciousness]. Fell into a coma [coma]. Septic shock [septic shock]. Vaginal sample numerous e. Coli and streptococci; cocci gram (+) quite. Numerous; bacilli gram (+) some [bacterial test positive]. Pv relatively inflammatory [vaginal inflammation]. Case description: the mother of a (b)(6)-year-old female reported that her daughter used tampax tampon, version/absorbency/scent unknown beginning on an unspecified date, and she had toxic shock twice; once in (b)(6)2014, and once in (b)(6)2014. She now has to live with having toxic shock syndrome. No further information was provided. (b)(6)2014 consumer relations follow-up phone call with the mother: the mother reported that her daughter first experienced toxic shock syndrome on (b)(6)2014, and was hospitalized for 1 week in intensive care. The second episode occurred on (b)(6)2014; she started vomiting, had a high fever, and fell unconscious and into a coma. She was treated with a high dose of intravenous adrenaline, very strong antibiotics, and penicillin. She is better physically, but she is very psychologically affected and will be seeing a psychiatrist. She stated her daughter lives with the syndrome every day. She had used tampax since her first period, but now she is not permitted to use tampons for the rest of her life. The case outcome was improved. No further information was provided. On (b)(6)2015 follow-up phone call with general practitioner: the physician reported that she is awaiting the final opinion of specialists regarding this case. The hospital where the consumer first sought treatment had asked for an additional opinion from another hospital. The consumer had also asked for the opinion of someone in another location. The physician reported that the consumer's daughter had likely used tampons a second time. It was not confirmed whether the tampon was the cause. No further information was provided. On (b)(6)2015 consumer relations received follow-up letter from consumer's mother, email from physician to mother, physician to physician letter, and laboratory results: the mother's letter reported that she obtained a second physician's opinion supporting toxic shock syndrome. Her daughter was currently under the care of a third physician. Email from physician who provided a second opinion to the consumer's mother: the physician reviewed the daughter's medical record, and reported that she showed all the criteria for a diagnosis of toxic shock due to staphylococcus. He recommended the discontinuation of tampon use. Consulting physician's letter to physician colleague: the physician stated he saw the patient, whose background involved two episodes of septic shock during the course of her menstrual period with the cause reported as the use of tampons. A vaginal sample taken gave evidence of numerous e. Coli and streptococci. Tests of chlamydia and mycoplasma were negative. She was prescribed ery 500, polygynax and cyteal, her oral contraception was renewed, and she was advised against the use of tampons. A bacteriological test was planned to be carried out in three months. The overall case outcome remained improved. No further information was provided. On 24-mar-2015 product investigation conclusion: no lot information was provided and no samples associated with this complaint have been received for evaluation. A review of adverse event surveillance data for the previous 12 months indicated no trends or signals for the reported issue. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[96987501]
Lot number or product was not provided by the reporter.
Patient Sequence No: 1, Text Type: N, H10
[96987502]
Toxic shock syndrome [toxic shock syndrome]. Vomiting [vomiting]. High fever [pyrexia]. Fell unconscious [loss of consciousness]. Fell into a coma [coma]. Septic shock [septic shock]. Vaginal sample numerous e. Coli and streptococci; cocci gram (+) quite. Numerous; bacilli gram (+) some [bacterial test positive]. Pv relatively inflammatory [vaginal inflammation]. Case description: the mother of a (b)(6) female reported that her daughter used tampax tampon, version/absorbency/scent unknown beginning on an unspecified date, and she had toxic shock twice; once in (b)(6) 2014, and once in (b)(6) 2014. She now has to live with having toxic shock syndrome. No further information was provided. On 23-jan-2014 consumer relations follow-up phone call with the mother: the mother reported that her daughter first experienced toxic shock syndrome on (b)(6) 2014, and was hospitalized for 1 week in intensive care. The second episode occurred on (b)(6) 2014; she started vomiting, had a high fever, and fell unconscious and into a coma. She was treated with a high dose of intravenous adrenaline, very strong antibiotics, and penicillin. She is better physically, but she is very psychologically affected and will be seeing a psychiatrist. She stated her daughter lives with the syndrome every day. She had used tampax since her first period, but now she is not permitted to use tampons for the rest of her life. The case outcome was improved. No further information was provided. On 26-jan-2015 follow-up phone call with general practitioner: the physician reported that she is awaiting the final opinion of specialists regarding this case. The hospital where the consumer first sought treatment had asked for an additional opinion from another hospital. The consumer had also asked for the opinion of someone in another location. The physician reported that the consumer's daughter had likely used tampons a second time. It was not confirmed whether the tampon was the cause. No further information was provided. On 25-feb-2015 consumer relations received follow-up letter from consumer's mother, email from physician to mother, physician to physician letter, and laboratory results: the mother's letter reported that she obtained a second physician's opinion supporting toxic shock syndrome. Her daughter was currently under the care of a third physician. Email from physician who provided a second opinion to the consumer's mother: the physician reviewed the daughter's medical record, and reported that she showed all the criteria for a diagnosis of toxic shock due to staphylococcus. He recommended the discontinuation of tampon use. Consulting physician's letter to physician colleague: the physician stated he saw the patient, whose background involved two episodes of septic shock during the course of her menstrual period with the cause reported as the use of tampons. A vaginal sample taken gave evidence of numerous e. Coli and streptococci. Tests of chlamydia and mycoplasma were negative. She was prescribed ery 500, polygynax and cyteal, her oral contraception was renewed, and she was advised against the use of tampons. A bacteriological test was planned to be carried out in three months. The overall case outcome remained improved. No further information was provided. On 24-mar-2015 product investigation conclusion: no lot information was provided and no samples associated with this complaint have been received for evaluation. A review of adverse event surveillance data for the previous 12 months indicated no trends or signals for the reported issue. No further information was provided. On 22-sep-2015 received follow-up email from consumer's mother: the mother reported the product used was tampax compak tampon, super plus unscented, and her daughter contracted tss in 2014 due to the tampons. She stated her daughter is not allowed to use tampons, but the damage is done for life. No further information was provided. On 27-dec-2015 received follow-up email from consumer's mother: the mother reported that her daughter contracted tss on (b)(6) 2014 due to tampax compak tampon, super plus unscented. She reported her daughter goes to the emergency room every month, has experienced edema, fungal infections, and infections, and has undergone unspecified testing. The outcomes of the reported events were unknown. The overall case outcome remained improved. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219109-2015-00003 |
| MDR Report Key | 4815858 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-06-03 |
| Date of Report | 2015-01-21 |
| Date of Event | 2014-10-11 |
| Date Mfgr Received | 2015-09-22 |
| Date Added to Maude | 2015-06-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. REGULATORY FEMININE CARE |
| Manufacturer Street | 6110 CENTER HILL AVENUE WINTON HILL BUSINESS CTR |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer Phone | 5136225206 |
| Manufacturer G1 | TAMBRANDS MANUFACTURING, INC |
| Manufacturer Street | 2879 HOTEL ROAD |
| Manufacturer City | AUBURN ME 04210 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 04210 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK |
| Generic Name | TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK |
| Product Code | HIL |
| Date Received | 2015-06-03 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAMBRANDS MANUFACTURING, INC. |
| Manufacturer Address | AUBURN ME US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-06-03 |