MAUDE Adverse Event Report: DEPENDS; DISPOSABLE UNDERWEAR

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2015

Event Type  Other  

Event Description

The consumer indicates that she used a pair of disposable underwear and noticed that they had parasites in the crotch region.The consumer indicates that she checked other disposable underwear she owns and that she has never used and that they too have parasites on them.The consumer indicates that the parasites "play possum" and only move about the five or ten minutes later.The consumer believes the issue might be due to the fact that the product is made from recycled material, or maybe because they have a "powdery" substance which the parasites may be attracted to.The consumer believes this product poses a safety hazard to consumers.(b)(4).(b)(6).The product number was not modified before the incident.If not, do you plan to contact the mfr: yes.

• Brand Name: DEPENDS
• Type of Device: DISPOSABLE UNDERWEAR
• MDR Report Key: 5290538
• MDR Text Key: 33363412
• Report Number: MW5058439
• 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
• Type of Report: Initial
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1