MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-04-12 for PLAYTEX SPORT REGULAR UNSCENTED TAMPON 14CT manufactured by Playtex Manufacturing, Inc..
[20353281]
On (b)(6) 2013, a consumer contacted energizer personal care (epc) to report an incident involving a playtex sport tampon. The consumer reported that instead of a pledget, the applicator for a tampon she attempted to use contained a foreign article, which she later discovered was compressed tinfoil. The consumer reported that when she purchased the product, the exterior box (unit carton) packaging appeared sealed. She observed nothing unusual about the product applicator when she removed it from the box and wrapper, and she was able to insert the applicator and the presumed tampon without difficulty. Following insertion, however, she noticed there was no string and later found she could not remove the foreign article. The consumer reported that the foreign article was inside her body for 24 hours. She further reported that during that time she experienced severe cramps, burning upon urination, and difficulty walking. She tried but was unable to remove the foreign article on her own and ultimately required her husband's assistance. Eventually, the consumer and her husband were able to remove the foreign article at home using a hemostat. The consumer and her husband reported that the foreign article was tinfoil compressed into the shape of a tampon. The consumer reported that she saw her doctor the following monday. The doctor performed an internal examination and diagnosed her with an internal abrasion. The consumer provided medical records to epc indicating a prescription for hydrocodone apap (percocet) 7. 5, metronidazole (flagyl) 500mg, lidocaine 2% jelly, and urogesic blue samples. The patient progress notes state that in a follow-up call from the doctor's office, the consumer reported feeling better. Epc spoke with the consumer on (b)(6), and she again reported feeling better. She also indicated that her doctor took blood samples and vaginal samples and that she is still awaiting the results of those tests. Epc followed up again on (b)(6) but did not learn anything about the test results.
Patient Sequence No: 1, Text Type: D, B5
[20421122]
The consumer returned the foreign article and the remaining (13 out of 14) unused tampons with the original unit carton to epc. Epc quality assurance (qa) examined the foreign article and after a thorough on-site inspection of its manufacturing floor determined that the material comprising the foreign article is not used anywhere in epc's manufacturing process. In addition, epc qa followed the manufacturing process flow to identify and review all process checks to prevent metal contamination in tampon products. Metal contamination is controlled in the webbing process by magnets, and in the forming and pack routines by metal detectors. To test these controls, epc ran two different sizes of compressed aluminum foil through the forming and pack metal detectors. In all tests, the controls detected the aluminum and rejected the test article. Epc also sent the actual foreign article found by the consumer through the metal detector and packaged inside a unit carton. It too was detected and rejected by the process controls. Epc qa also reviewed the device history record (dhr) for th e date code on the returned unit carton. No issues were found. The dhr for that date code also shows the metal detector passed all checks. Epc examined the 13 unused tampons returned by the consumer. The wrapping for each tampon was sealed and each applicator contains a fiber pledget. None contains tinfoil like the foreign article reported by the consumer. Epc examination of the unit carton showed evidence suggesting that the glue seal on the bottom of the unit carton had been reapplied. Epc is investigating the suspect glue seal to determine if it is consistent with ipc manufacturing. Although epc is continuing to investigate, its initial conclusion is that this event is the result of tampering, not a manufacturing error. To date, epc has not received any further reports of similar incidents involving any of its products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2515444-2013-00002 |
| MDR Report Key | 3062912 |
| Report Source | 04 |
| Date Received | 2013-04-12 |
| Date of Report | 2013-04-12 |
| Date of Event | 2013-03-05 |
| Date Mfgr Received | 2013-03-12 |
| Device Manufacturer Date | 2012-11-19 |
| Date Added to Maude | 2013-04-18 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER REMPE, DIRECTOR |
| Manufacturer Street | 6 RESEARCH DRIVE |
| Manufacturer City | SHELTON CT 06484 |
| Manufacturer Country | US |
| Manufacturer Postal | 06484 |
| Manufacturer Phone | 2017858110 |
| Manufacturer G1 | PLAYTEX MANUFACTURING INC. |
| Manufacturer Street | 804 WALKER RD. |
| Manufacturer City | DOVER DE 19904 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19904 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLAYTEX SPORT REGULAR UNSCENTED TAMPON 14CT |
| Product Code | HIL |
| Date Received | 2013-04-12 |
| Returned To Mfg | 2013-03-26 |
| Lot Number | 12323AE |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLAYTEX MANUFACTURING, INC. |
| Manufacturer Address | DOVER DE 19904 US 19904 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-04-12 |