MAUDE Adverse Event Report: HYGINETT HUNGARIAN AMERICAN CO TAMPAXTAMPONSPEARL; TAMPON, MENSTRUAL, UNSCENTED

Lot Number NOT AVAILABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Pain (1994); Discomfort (2330); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Product and lot number not provided by the reporter, therefore, unable to proceed with product investigation at this time.

Event Description

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.

• Brand Name: TAMPAXTAMPONSPEARL
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): HYGINETT HUNGARIAN AMERICAN CO; hatar u.3; csomor, ; HU
• Manufacturer (Section G): HYGINETT HUNGARIAN AMERICAN CO; hatar u.3; csomor, ; HU
• Manufacturer Contact: regulatory feminine care ; 6110 center hill avenue; cincinnati, OH 45224
• MDR Report Key: 6247636
• MDR Text Key: 64708818
• Report Number: 3004443383-2017-00001
• Device Sequence Number: 1
• Product Code: HIL
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K011996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: NOT AVAILABLE
• Other Device ID Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention