MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-09-22 for PLAYTEX SPORT, MULITPACK, SCENTED TAMPONS manufactured by Playtex Products, Inc..
[1260545]
Received a report from a customer indicating she has made an appointment with her doctor for an examination, and assistance in removing a piece of a tampon pledget that has separated, and remained behind during removal of a tampon.
Patient Sequence No: 1, Text Type: D, B5
[8372682]
Verbally advised lot code info provided by the reporter has been sent to quality assurance for investigation. We await the results. We have requested, and await the consumer's return of product for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515444-2009-00009 |
| MDR Report Key | 1481692 |
| Report Source | 07 |
| Date Received | 2009-09-22 |
| Date of Report | 2009-09-22 |
| Date of Event | 2009-08-17 |
| Date Mfgr Received | 2009-08-17 |
| Date Added to Maude | 2009-09-25 |
| 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, MULITPACK, SCENTED TAMPONS |
| Generic Name | TAMPON |
| Product Code | HIL |
| Date Received | 2009-09-22 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 09022AB |
| 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 19900 US 19900 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-09-22 |