MAUDE Adverse Event Report: WALMART MAXIMUM ASSURANCE ; DISPOSABLE UNDERWEAR

Device Problems Break (1069); Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Miscarriage (1962); Rash (2033); Pregnancy (3193)

Event Date 07/20/2015

Event Type  Injury  

Event Description

Am using (b)(6) brand underwear and have developed a rash on my buttocks up to my waistline.I usually use (b)(6) brand but were out of stock.I wear these underwear for an average nine hours during work and have them on for about ten hours.This has been ongoing for about three weeks.Have been using antibiotic cream and benadryl to ease the itch.I have just recently returned to work and don't always have time to get to restroom.Dates of use: three weeks.Reason fr use: weak bladder control.Event abated after use stopped or dose reduced: yes.Event reappeared after reintroduction: yes.

• Brand Name: MAXIMUM ASSURANCE
• Type of Device: DISPOSABLE UNDERWEAR
• Manufacturer (Section D): WALMART
• MDR Report Key: 5004385
• MDR Text Key: 23136529
• Report Number: MW5055386
• Device Sequence Number: 1
• Product Code: EYQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 70