MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-02-02 for PLAYTEX, GENTLE GLIDE, SUPER, SCENTED TAMPONS manufactured by Playtex Products, Inc..
[16416890]
Received a report from a consumer indicating she recently gave birth, and has since experienced only a few irregular menstrual cycles; wherein both gentle glide regular and super absorbency tampons were used. Consumer reported on one occasion each during last two menses, she experienced pieces of a tampon pledget being left behind, and expelling several hours after, the removal of the tampon pledget. Consumer did not know which absorbancy tampon was used during said incidents. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
[16565554]
We have requested and await consumer's return of product for evaluation. Lot code information advised by the reporter has been sent to qa for investigation. We await the results. Since reporter did not know which absorbancy was used during the described event, we have also submitted mfr report # 2515444201000002 for the other product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515444-2010-00001 |
| MDR Report Key | 1615358 |
| Report Source | 07 |
| Date Received | 2010-02-02 |
| Date of Report | 2010-02-01 |
| Date of Event | 2009-12-01 |
| Date Mfgr Received | 2010-01-05 |
| Date Added to Maude | 2010-09-07 |
| 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, GENTLE GLIDE, SUPER, SCENTED TAMPONS |
| Generic Name | TAMPON |
| Product Code | HIL |
| Date Received | 2010-02-02 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 07106Y |
| 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 | 2010-02-02 |