MAUDE Adverse Event Report: TAMBRANDS MANUFACTURING, INC TAMPAX COMPAK PEARL TAMPON UNSCENTED, ABSORBENCY UNKNOWN; TAMPON, MENSTRUAL, UNSCENTED

Lot Number NOT AVAILABLE

Device Problem Patient-Device Incompatibility (2682)

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

Event Type  Injury  

Event Description

Fibroma - vagina / fibroma due to friction [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 / stinging - vagina [vulvovaginal pain]; noticed a small injury, something like a scratch or fissure - vagina [vulvovaginal injury]; injury - tampon area [medical device site injury]; pinching - vagina [vaginal disorder].Case description: the consumer, a female of unspecified age, reported via e-mail on (b)(6) 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.On (b)(6) 2017 received consumer follow up phone call: the consumer, a (b)(6) year old female, reported that she was totally recovered.She experienced a fibroma due to friction and reported that it was a hypersensitive area beginning a year and a half or two years ago.The fibroma was removed and recovered after 3 months.Beginning a year and a half ago, she experienced stinging and pinching that stopped after six months.The consumer reported that they performed a biopsy on her and did not give her any treatment.She clarified that the product used was tampax tampons pearl compak and she stopped using the product over a year ago.She continued using tampax tampons but not the tampax compak pearl.She did not experience any problems with the other tampax tampons.She reported using one tampon every 4 hours during the day for 3 days.Allergies: some chrome metal and alloy but doesn't know which one.The case outcome was recovered.No further information was provided.

• Brand Name: TAMPAX COMPAK PEARL TAMPON UNSCENTED, ABSORBENCY UNKNOWN
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): TAMBRANDS MANUFACTURING, INC; 2879 hotel road; auburn ME 04210
• Manufacturer (Section G): TAMBRANDS MANUFACTURING, INC; 2879 hotel road; auburn ME 04210
• Manufacturer Contact: regulatory feminine care ; 6110 center hill avenue; cincinnati, OH 45224
• MDR Report Key: 6447764
• MDR Text Key: 71395168
• Report Number: 1219109-2017-00004
• Device Sequence Number: 1
• Product Code: HEB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K133244
• 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

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 03/02/2017
• Initial Date FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR