MAUDE Adverse Event Report: WALMART STORES ASSURANCE WOMENS INCONTINENCE UNDERWEAR; GARMENT, PROTECTIVE, FOR INCONTINENCE

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  Injury  

Event Description

The reporter called regarding assurance women's incontinence underwear.The reporter mentioned she bought this product from walmart.In the beginning the product was good but since couple of months the product smells like formaldehyde.The strong smell from underwear makes reporter nauseous and itchy.Also she didn't receive any positive response from the manufacturer, she is okay with her details shared with the manufacturer for further investigation.

• Brand Name: ASSURANCE WOMENS INCONTINENCE UNDERWEAR
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): WALMART STORES; 702 southwest 8th st.; bentonville AR 72716
• MDR Report Key: 18757946
• MDR Text Key: 335997487
• Report Number: MW5151793
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 104 KG