MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION POISE; GARMENT, PROTECTIVE, FOR INCONTINENCE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

Neither product model or manufacturer lot code were provided.With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and records can be performed.Complaints which are serious in nature are reviewed on a regular basis or for due cause to provide visibility and escalation.In addition, complaints are also monitored for trending on a monthly cadence.No further information is available at this time.

Event Description

A consumer called to report burning sensation/irritation with poise pads.During phone call she mentioned that her friend was in the hospital for burning sensation/rash and bladder infection from wearing poise pad.Neither the friend nor the friend's family have reached out to us to report this.Since we do not have her contact information, there is no way to follow up on progress, verify cause of hospitalization, and if the poise pad product was involved.Consumer stated she would encourage her to call in and report this incident.

• Brand Name: POISE
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION; 2100 winchester road; neenah WI 54956
• Manufacturer (Section G): KIMBERLY-CLARK CORPORATION; 2100 winchester road; neenah WI 54956
• Manufacturer Contact: marian vargas ; 2100 winchester road; neenah, WI 54956 ; 9207215889
• MDR Report Key: 7884807
• MDR Text Key: 120530324
• Report Number: 3003701733-2018-00051
• 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: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization