MAUDE Adverse Event Report: KIMBERLY CLARK CORP. POISE MICROLINERS; GARMENT, PROTECTIVE, FOR INCONTINENCE

Lot Number BJ823201X0028NO

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Irritation (1941); Itching Sensation (1943); Pain (1994); Blood Loss (2597)

Event Date 12/28/2018

Event Type  Injury  

Event Description

I used poise pads in the purple box, pantiliners, after anal polyp surgery to catch any spotting from my incision.After two days' use, i noticed that i had more than a little bleeding.My entire rectal, perineum area was red and itchy and inflamed.It was quite painful.Upon stopping the use of the pads and treating the area with cortisone ointment, zinc oxide, and bacitracin ointment, the inflammation and itching and bleeding ceased.I will never use the poise pantiliner products again as something in the product caused much irritation to my nether regions.Is the product over-the-counter? yes; did the problem stop after the person reduced the dose or stopped taking or using the product? yes; did the product problem return if the person started taking or using the product again? yes; date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018.

• Brand Name: POISE MICROLINERS
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY CLARK CORP.
• MDR Report Key: 8212612
• MDR Text Key: 132234174
• Report Number: MW5082767
• 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: 12/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: BJ823201X0028NO
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR