MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-01-14 for O.B. ORIGINAL TAMPONS manufactured by Johnson & Johnson.
[4066993]
An o. B. Tampon user called to report she was diagnosed with tss in 1991 and never treated. At the time of her diagnosis she was using o. B. Tampons. User states she had numerous diagnoses and treatments for various ailments over the years and has been disabled for 14 years. She has a rash on her face, is losing her hair, and has lung and intestinal issues as well as vaginal discomfort.
Patient Sequence No: 1, Text Type: D, B5
[11489515]
Energizer personal care, llc is submitting this report only because an event meeting the requirements of 21 cfr 803 may have occurred. This does not mean that an energizer product malfunctioned or that an energizer product was, in fact, associated with an actual consumer injury. Consequently, the report must not be construed as an admission of any kind by energizer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515444-2014-00001 |
| MDR Report Key | 3595404 |
| Report Source | 04 |
| Date Received | 2014-01-14 |
| Date of Report | 2014-10-14 |
| Date of Event | 1991-01-01 |
| Date Mfgr Received | 2013-11-26 |
| Date Added to Maude | 2014-01-29 |
| 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 Contact | JENNIFER REMPE |
| Manufacturer Street | 6 RESEARCH DRIVE |
| Manufacturer City | SHELTON CT 06484 |
| Manufacturer Country | US |
| Manufacturer Postal | 06484 |
| Manufacturer Street | 710-1, RUE NOTRE-DAME EST |
| Manufacturer City | MONTREAL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | O.B. ORIGINAL TAMPONS |
| Generic Name | O.B. TAMPONS |
| Product Code | HIL |
| Date Received | 2014-01-14 |
| 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 | JOHNSON & JOHNSON |
| Manufacturer Address | MONTREAL CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2014-01-14 |