MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2013-11-22 for TAMPAX PEARL TAMPON, SUPER SCENT UNK manufactured by Tambrands Manufacturing, Inc..
[3965653]
Toxic shock syndrome [toxic shock syndrome], partially collapsed lung [pneumothorax], pericardial effusion [pericardial effusion], blood poisoning [sepsis], vomiting [vomiting], severe diarrhea [diarrhoea], feeling unwell/illness [malaise], lack of energy [asthenia], did not have appetite [decreased appetite], fatigued [fatigue], did not have the mental faculties to seek help [mental impairment], slipped in and out of consciousness [consciousness fluctuating], barely able to breathe [dyspnoea], vastly accelerated pulse [heart rate increased], skyrocketing blood pressure [blood pressure increased], icu ptsd [post-traumatic stress disorder], anxiety [anxiety], pain [pain], disoriented [disorientation]. Case description: a consumer reported that they, a female age (b)(6) years, used tampax pearl tampon, super scent unknown tampon concurrently with tampax pearl tampon, super plus scent unknown, changing the tampon about every four hours during her period and reported that on (b)(6) 2013, she came down with what she thought were symptoms of a common stomach virus. On the evening of (b)(6) 2013, after feeling unwell for several hours she began vomiting. The consumer rested in bed during this time and took in extra fluids to replace fluids lost. The consumer noticed a lack of energy and loss of appetite. The consumer began to feel better but fatigued then awoke with severe diarrhea and within two hours had blood poisoning. Her husband checked on her during the night as she did not have the mental faculties to seek help and was able to wake her but she slipped in and out of consciousness easily without stimulation. He took her to the emergency department and she was admitted. The consumer had a partially collapsed lung and a pericardial effusion. She spent 10 days in the intensive care unit and during that time she was in tremendous pain, disoriented, barely able to breathe, had a vastly accelerated pulse and skyrocketing blood pressure. The infectious disease specialist ran tests and confirmed a diagnosis of toxic shock syndrome. The consumer reported that her condition improved over the next 8 days. She reported that now she was suffering from anxiety and intensive care unit post-traumatic stress disorder requiring treatment by a therapist. Hospital treatment included: 3 iv lines, a central line, arterial line, transfusion of fresh frozen plasma (a blood product), several penicillin-based antibiotics, morphine, tube feeding and potassium drink. The case outcome was improved. Other product used previously without incident: used tampax brand for 23 years. No further information was provided. Date: (b)(6) 2013, consumer follow-up contact: the consumer reported that she was still recovering and she did not have a lot of energy. The consumer still had some fluid around her heart. She no longer had the product; threw it out. The consumer reported that she used tampax pearl super and pearl super plus interchangeably during her period and had used them for 3 days prior to the illness ((b)(6) 2013). No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[11384007]
Lot number or product was not provided by the reporter; therefore, unable to proceed with batch retain testing or product investigation. The consumer discarded the product. Reason that the device has not been evaluated by the manufacturer: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2013-00009 |
| MDR Report Key | 3514975 |
| Report Source | 01,04 |
| Date Received | 2013-11-22 |
| Date of Report | 2013-11-13 |
| Date Mfgr Received | 2013-11-13 |
| Date Added to Maude | 2013-12-16 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6110 CENTER HILL AVE. WINTON HILL BUSINESS CENTER |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | TAMBRANDS MANUFACTURING, INC. |
| Manufacturer Street | 2879 HOTEL RD. |
| 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 PEARL TAMPON, SUPER SCENT UNK |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2013-11-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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; 2. Other | 2013-11-22 |