MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-05-01 for TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK manufactured by Tambrands Manufacturing, Inc.
[20726842]
Toxic shock syndrome [toxic shock syndrome], vomiting [vomiting], high fever [pyrexia], fell unconscious [ loss of consciousness], fell into a coma[coma]. Case description: the mother of a (b)(6)-year old female reported that her daughter used tampax tampon, version/absorbency/scent unk beginning on an unspecified date, and she had toxic shock twice; once in (b)(6) 2014. She now has to live with having toxic shock syndrome. No further info was provided. On (b)(6) 2014: consumer relations f/u 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 fel 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 info was provided. On (b)(6) 2015: f/u phone call with general practitioner: the physician reported that she is awaiting the final opinion of specialists regarding this case. The hosp where the consumer first sought treatment had asked for an additional opinion from another hosp. 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 info was provided.
Patient Sequence No: 1, Text Type: D, B5
[21038935]
Lot number or product was not provided by the reporter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004443383-2015-00001 |
| MDR Report Key | 4768489 |
| Report Source | 01,05 |
| Date Received | 2015-05-01 |
| Date of Report | 2015-01-21 |
| Date of Event | 2014-10-11 |
| Date Mfgr Received | 2015-01-23 |
| Date Added to Maude | 2015-05-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ,MGR |
| Manufacturer Street | WINTON HILL BUSINESS CTR 6110 CENTER HILL AVE |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | HYGINETT HUNGARIAN AMERICAN CO. |
| Manufacturer Street | HATAR U.3 |
| Manufacturer City | CSOMOR 2141 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 2141 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK |
| Generic Name | NI |
| Product Code | HIL |
| Date Received | 2015-05-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-05-01 |