MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-20 for PLAYTEX SPORT 18 FLEXFIT REGULAR TAMPONS W/ FIBERS manufactured by Playtex.
[3588000]
Playtex tampons left cotton fibers behind, inside body, had to be taken out (this can cause toxic shock syndrome). Playtex sport tampons used. Tampon fibers separated from tampon and were left inside body. This is dangerous. Called playtex, they should be sending a prepaid tag to return product. Why was the person using the product: period. Did the problem stop after the person reduced the dose or stopped taking or using the product: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031566 |
| MDR Report Key | 3305443 |
| Date Received | 2013-08-20 |
| Date of Report | 2013-08-14 |
| Date of Event | 2013-08-01 |
| Date Added to Maude | 2013-08-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLAYTEX SPORT 18 FLEXFIT REGULAR TAMPONS W/ FIBERS |
| Generic Name | PLAYTEX SPORT 18 FLEXFIT REGULAR TAMPONS W/ FIBERS |
| Product Code | HIL |
| Date Received | 2013-08-20 |
| Lot Number | 12262AE |
| ID Number | 08108J0/078300081081 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLAYTEX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-20 |