MAUDE Adverse Event Report: PLAYTEX MANUFACTURING, INC. PLAYTEX SPORT TAMPONS, SUPER+ UNSCENTED 36 CT.; TAMPON, MENSTRUAL, UNSCENTED: PRODUCT CODE: HEB

Lot Number	16048AC
Health Effect - Clinical Codes	Prolapse (2475); Patient Problem/Medical Problem (2688)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
This (b)(6) female consumer reported that she removed a super plus tampon with some difficulty and later noticed that her vagina was not right.Consumer did not know the actual date but stated that about six months back she went to the doctor and was diagnosed with interior/exterior wall vaginal prolapse.The consumer stated that treatment was not provided but that she was told that they can do a non-invasive laser procedure or a surgery.The consumer stated that she was not interested in surgery but would consider laser treatment.On (b)(6) 2018 the consumer reported that prior to seeking medical attention she had and currently has vaginal discomfort and pain with intercourse.She stated that the vaginal discomfort has affected her quality of life and the person that she is because it has caused her pain during intercourse.The consumer stated that she is now looking to do the non-invasive procedure involving laser and needs financial help.According to the medical record received from her physician, the consumer was seen on (b)(6) 2017 for assessment of dyspareunia and prolapse.Her medical history included gravida 3 / para 3, three cesarean sections, no allergies and occasional smoking.She takes no regular medications.She had noticed increasing dyspareunia and pelvic discomfort.She had a period one month prior but they have been irregular for the past six months and she was having some hot flushes and sweats.On examination she had a grade 1-2 cystocele, grade 2-3 rectocele and no uterine prolapse.At that time she was not interested in surgical management, did not want vaginal estrogen but stated she would consider mona lisa laser treatment for vaginal dryness.

• Brand Name: PLAYTEX SPORT TAMPONS, SUPER+ UNSCENTED 36 CT.
• Common Device Name: TAMPON, MENSTRUAL, UNSCENTED: PRODUCT CODE: HEB
• Manufacturer (Section D): PLAYTEX MANUFACTURING, INC.; 804 walker rd; dover DE 19904
• MDR Report Key: 7952669
• Report Number: 2515444-2018-00003
• Device Sequence Number: 1190666
• Product Code: HEB
• UDI-Device Identifier: 00078300081364
• UDI-Public: 078300081364
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K132819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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
• Operator of Device: Lay User/Patient
• Device Lot Number: 16048AC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 49 YR