MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-07-22 for PLAYTEX GENTLE GLIDE, REGULAR, SCENTED TAMPONS manufactured by Playtex Products, Inc..
[1604215]
Received a report from consumer's mother indicating on (b) (6) 2010, her daughter felt ill while using tampons during her menstrual cycle. On (b) (6) 2010, her daughter sought a medical examination and subsequently was admitted to a hospital where her condition deteriorated; wherein she experienced multi-system organ failure until her death on (b) (6) 2010. Please note limited information was provided by the reporter regarding her daughter's hospitalization, treatment, formal medical diagnosis, secondary diagnoses, etc; and no information was provided regarding other medical condition(s) that may have contributed to the reported adverse event.
Patient Sequence No: 1, Text Type: D, B5
[8724784]
Verbally advised lot code information provided by the reporter has been sent for investigation. We await the results. We have requested and await more information from the reporter regarding her daughter's experience and the return of the product for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515444-2010-00003 |
| MDR Report Key | 1769220 |
| Report Source | 07 |
| Date Received | 2010-07-22 |
| Date of Report | 2010-07-20 |
| Date of Event | 2010-06-08 |
| Date Mfgr Received | 2010-06-21 |
| Date Added to Maude | 2010-07-23 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET DEPALMA |
| Manufacturer Street | 75 COMMERCE DR |
| Manufacturer City | ALLENDALE NJ 07401 |
| Manufacturer Country | US |
| Manufacturer Postal | 07401 |
| Manufacturer Phone | 2017858000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLAYTEX GENTLE GLIDE, REGULAR, SCENTED TAMPONS |
| Generic Name | TAMPON |
| Product Code | HIL |
| Date Received | 2010-07-22 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 10083BA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLAYTEX PRODUCTS, INC. |
| Manufacturer Address | 804 WALKER RD DOVER DE 19990 US 19990 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-07-22 |