MAUDE Adverse Event Report: KIMBERLEY CLARK POISE PADS WITH WINGS; INCONTINENCE PADS

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Reaction (2414)

Event Date 12/10/2014

Event Type  Injury  

Event Description

My (b)(6) mother (us citizen and resident) used poise pads with wings for 1 week and developed an allergic reaction presenting as contact dermatitis; she now needs a course of anti-biotics alongside other interventions to overcome this condition.Her experience seems consistent with the many reports made of problems with using this device for the purposes for which it is marketed since kimberly clark changed some of the constituents of these pads in 2012.

• Brand Name: POISE PADS WITH WINGS
• Type of Device: INCONTINENCE PADS
• Manufacturer (Section D): KIMBERLEY CLARK
• MDR Report Key: 4342606
• MDR Text Key: 5217492
• Report Number: MW5039625
• Device Sequence Number: 1
• Product Code: EYQ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Weight: 44