MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-09-23 for PLAYTEX GENTLE GLIDE, SUPER PLUS, SCENTED TAMPONS manufactured by Playtex Products, Inc..
[1239998]
Received a report from a consumer indicating she sought medical assistance to remove a piece of a tampon pledget that had separated, and remained behind during removal of a tampon. Consumer advised the remaining piece was removed without incident, and she has fully recovered.
Patient Sequence No: 1, Text Type: D, B5
[8479587]
Reporter advised the lot code information of the product had been discarded. We have requested and await the consumer's return of product for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515444-2009-00011 |
| MDR Report Key | 1483025 |
| Report Source | 07 |
| Date Received | 2009-09-23 |
| Date of Report | 2009-09-23 |
| Date of Event | 2009-08-18 |
| Date Mfgr Received | 2009-08-18 |
| Date Added to Maude | 2009-09-29 |
| 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 | 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 GENTLE GLIDE, SUPER PLUS, SCENTED TAMPONS |
| Generic Name | TAMPON |
| Product Code | HIL |
| Date Received | 2009-09-23 |
| 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 | 2009-09-23 |