MAUDE Adverse Event Report: PLAYTEX MANUFACTURING INC. OB 40 CT PRO-COMFORT MULTIPACK UNSCENTED; TAMPON, MENSTRUAL, UNSCENTED

Lot Number 18260DA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Headache (1880); Nausea (1970); Vaginal Mucosa Damage (2124); Abdominal Cramps (2543)

Event Date 10/01/2018

Event Type  Injury  

Event Description

On (b)(6) 2019 a female consumer reported that she had been using ob tampons for years and years and in (b)(6) 2018 she started having pain and discomfort.She stated that she went to the emergency room where they tested her for drugs, checked her t-cell count and did a pregnancy test.She stated that they did not believe her and thought she was trying to get drugs so referred her to a psychiatrist.She stated that she stopped using tampons until (b)(6) 2019 and after a few days the tampons gave her the same symptoms as in (b)(6) 2018, nausea, headache and cramps and she was in a lot of pain.Consumer stated that she was taking naproxen for cramps.Consumer stated that prior to the emergency room visit in (b)(6) 2018, she saw her primary care physician (pcp) for pelvic discomfort and appendicitis was ruled out, pelvic and vaginal ultrasounds were negative and nothing was found.She stated that when she discontinued using the product her symptoms improved.Consumer reported that her pcp examined her on (b)(6) 2019 and stated that she "appeared to have irritated white cells".She stated that she has not seen her ob-gyn doctor since (b)(6) 2018 when a pap test was done.She stated that she was not being treated for infertility but is using the ovia fertility app to monitor her ovulation for invitro fertilization.She stated that while she was not using the tampons, her period was "right on" but since using the tampons again her period was a week early, she has not ovulated and is currently having vaginal itching and burning.Consumer expressed concern that the tampons were causing her not to have a baby and she has requested a warning be put on the packaging that the tampons can cause fertility issues.

• Brand Name: OB 40 CT PRO-COMFORT MULTIPACK UNSCENTED
• Type of Device: TAMPON, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): PLAYTEX MANUFACTURING INC.; 804 walker rd, dover,; dover DE 19904
• Manufacturer (Section G): EDGEWELL PERSONAL CARE BRANDS; 804 walker rd; dover DE 19904
• Manufacturer Contact: janet gonzalez ; 75 commerce drive; allendale, NJ 07401 ; 2017858047
• MDR Report Key: 8718378
• MDR Text Key: 148657783
• Report Number: 2515444-2019-00005
• Device Sequence Number: 1
• Product Code: HEB
• UDI-Device Identifier: 00078300070153
• UDI-Public: 078300070153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 18260DA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR