MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-10-27 for TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK (NOT APPLICABLE) TAMPON 1APPLIC manufactured by Tambrands Manufacturing, Inc..
[2218724]
Pre-cancerous cells on cervix [precancerous cells present], abnormal pap smear [smear cervix abnormal]. Case description: a consumer reported that they, an adult female age (b)(6), used tampax tampons, version/absorbency/scent unk, unspecified total daily use since she was a teenager, and reported the following: has pre-cancerous cells on her cervix, has had abnormal pap smears for many years. The consumer had visited her physician. She had a leep (loop electrocautery excision procedure) and a cervical cone biopsy, but continued to use the tampons and continued having abnormal pap smears. She discontinued use of tampons a couple of years ago and entered a period of celibacy for 4 years; she has not had an abnormal pap smear since that time. The case outcome was not recovered/not resolved. Past medical history included: drug allergy - flagyl, gabapentin, and lyrica, concurrent condition-entered a period of celibacy for 4 years. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5
[9377407]
Lot number was not provided by consumer, therefore, unable to proceed with lot check/batch retain request. A product sample was not provided by the consumer, therefore, unable to proceed with product investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219109-2011-00010 |
| MDR Report Key | 2326576 |
| Report Source | 04 |
| Date Received | 2011-10-27 |
| Date of Report | 2011-10-13 |
| Date Mfgr Received | 2011-10-13 |
| Date Added to Maude | 2012-07-12 |
| 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 | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 6110 CENTER HILL AVE FEMININE CARE-SEE COVER LTR |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | TAMBRANDS MFG, INC |
| Manufacturer Street | 2879 HOTEL RD. |
| Manufacturer City | AUBURN ME 04210 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 04210 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNK (NOT APPLICABLE) TAMPON 1APPLIC |
| Generic Name | NONE |
| Product Code | HIL |
| Date Received | 2011-10-27 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAMBRANDS MANUFACTURING, INC. |
| Manufacturer Address | AUBURN ME US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-27 |