MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2017-01-12 for TAMPAXTAMPONSPEARL manufactured by Hyginett Hungarian American Co.
[64708818]
Product and lot number not provided by the reporter, therefore, unable to proceed with product investigation at this time.
Patient Sequence No: 1, Text Type: N, H10
[64708819]
Fibroma - vagina [fibroma]; discomfort in lower portion of vagina [vulvovaginal discomfort]; pain around tampon cord [medical device site pain]; discomfort - from tampon [medical device site discomfort]; pain - vagina [vulvovaginal pain]; noticed a small injury, something like a scratch or fissure - vagina [vulvovaginal injury]; injury - tampon area [medical device site injury]. Case description: the consumer, a female of unspecified age, reported via e-mail on 13-dec-2016, that she used tampax tampons pearl beginning on an unspecified date and experienced the following symptoms beginning on an unspecified date: small injury (something like a scratch, a fissure), feeling some discomfort in the lower portion of vagina, and strong pain around the tampon cord during menstruation. The consumer went to her doctor and it seemed like a small tear and she could not figure out how it happened. The consumer switched back to the regular tampax and all of her ailments went away. She visited a gynecologist who told her it was a small fibroma which had to be removed and sent for biopsy. Treatment: had to undergo two small surgeries. The consumer went back to using the tampax tampons pearl again and within two or three cycles and she had a new injury. She reported that the gynecologist forbid her from using them because he thought the problem had been caused exclusively by using tampax. She had used the product regularly of a number of years. The consumer had previously used compact tampax with applicator and the "regular ones" (those that have a cotton cord) which caused no injuries to her. Allergies: latex and other products containing cellulose, as well as some feminine pads that use them in their products or processing. Concomitant product(s): none reported. The case outcome was unknown. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004443383-2017-00001 |
| MDR Report Key | 6247636 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2017-01-12 |
| Date of Report | 2016-12-13 |
| Date Mfgr Received | 2016-12-13 |
| Date Added to Maude | 2017-01-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MGR. REGULATORY FEMININE CARE |
| Manufacturer Street | 6110 CENTER HILL AVENUE |
| Manufacturer City | CINCINNATI OH 45224 |
| Manufacturer Country | US |
| Manufacturer Postal | 45224 |
| Manufacturer G1 | HYGINETT HUNGARIAN AMERICAN CO |
| Manufacturer Street | HATAR U.3 |
| Manufacturer City | CSOMOR, |
| Manufacturer Country | HU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAMPAXTAMPONSPEARL |
| Generic Name | TAMPON, MENSTRUAL, UNSCENTED |
| Product Code | HIL |
| Date Received | 2017-01-12 |
| Lot Number | NOT AVAILABLE |
| ID Number | NOT AVAILABLE |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYGINETT HUNGARIAN AMERICAN CO |
| Manufacturer Address | HATAR U.3 CSOMOR, HU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-01-12 |