MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-08-11 for PLAYTEX, SPORT, REGULAR, FRESH SCENT TAMPONS manufactured by Playtex Products, Inc..
[1529836]
Received a report from a consumer indicating that during removal of a tampon, the pledget "broke in half"; a portion of the tampon pledget separated and remained behind. The consumer was able to remove the remaining piece without incident. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8774449]
We have requested and await consumer's return of product for eval. Lot code info advised by the reporter has been sent to qa for investigation. We await the results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515444-2010-00004 |
| MDR Report Key | 1804380 |
| Report Source | 07 |
| Date Received | 2010-08-11 |
| Date of Report | 2010-08-11 |
| Date of Event | 2010-07-14 |
| Date Mfgr Received | 2010-07-14 |
| Date Added to Maude | 2011-02-14 |
| 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 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, SPORT, REGULAR, FRESH SCENT TAMPONS |
| Generic Name | TAMPON |
| Product Code | HIL |
| Date Received | 2010-08-11 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 10155A |
| ID Number | NA |
| 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 | 2010-08-11 |