MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-03-17 for TAMPAX PEARL TAMPON, REGULAR SCENT UNK manufactured by Tambrands Manufacturing, Inc..
[16462848]
Tss[toxic shock syndrome], stomach pain[abdominal pain upper], throwing up; vomiting[vomiting], diarrhea[diarrhoea], started itching[pruritus]skin red [erythema] felt pressure build up in head, felt like the blood was running to head[head discomfort] lost hearing temporarily[deafness transitory]began to lose vision, it got starry and then dark {blindness] all over rash [rash generalised] headache[headache] swelling[swelling] case description: on (b)(6) 2014, a female consumer of unspecified age reported she had used (b)(6) pearl tampon, regular unscented on an unspecified date and got toxic shock syndrome. The consumer reported that she woke up with the worst stomach pain possible, she had diarrhea, was throwing up, started itching, her skin became red, she felt pressure build up in her head, she lost her hearing temporarily, and began to lose her vision, stating it got starry and dark. She managed to call 911 and have an ambulance pick her up. Consumer states she almost died. The case outcome is unknown. No further information is provided. On (b)(6) 2015 lot check result received: lot check performed spanning 7 months. This case was the only case found for this lot code.
Patient Sequence No: 1, Text Type: D, B5
[16619516]
On (b)(6) 2015, the consumer returned three wrapped pearl regular tampons with lot code 4242243065. Visual inspection of the samples did not confirm the alleged defect. In addition, three retain samples from the subject lot were visually inspected and no defects were observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2015-00002 |
| MDR Report Key | 4615568 |
| Report Source | 04 |
| Date Received | 2015-03-17 |
| Date of Report | 2014-12-10 |
| Date of Event | 2014-12-11 |
| Date Mfgr Received | 2015-02-19 |
| Date Added to Maude | 2015-03-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | WINTON HILL BUSINESS CTR 6110 CENTER HILL AVE |
| 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, REGULAR SCENT UNK |
| Generic Name | UNK |
| Product Code | HIL |
| Date Received | 2015-03-17 |
| Returned To Mfg | 2015-01-12 |
| Lot Number | 4242243065 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-03-17 |