MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-09-17 for PLAYTEX SPORT, MULTIPACK, SCENTED TAMPONS manufactured by Playtex Products, Inc..
[1662384]
Received a report from a consumer indicating she sought a medical examination for cramping and discomfort several weeks after the end of her last menses. Consumer indicated her physician removed a piece of a tampon pledget without incident, and she has since fully recovered.
Patient Sequence No: 1, Text Type: D, B5
[8704505]
We have requested and await the consumer's return of product for evaluation and date code information for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515444-2010-00006 |
| MDR Report Key | 1845885 |
| Report Source | 07 |
| Date Received | 2010-09-17 |
| Date of Report | 2010-09-17 |
| Date of Event | 2010-08-01 |
| Date Mfgr Received | 2010-08-20 |
| Date Added to Maude | 2010-09-30 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET DEPALMA |
| Manufacturer Street | 75 COMMERCE DRIVE |
| 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 SPORT, MULTIPACK, SCENTED TAMPONS |
| Generic Name | TAMPON |
| Product Code | HIL |
| Date Received | 2010-09-17 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| 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 ROAD DOVER DE 19990 US 19990 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-09-17 |