MAUDE Adverse Event Report: KIMBERLY-CLARK GLOBALSALES, LLC POISE; POISE MICROLINES (LIGHT BLADDER LEAKAGE PROTECTION)

Model Number POISE MICROLINERS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Urinary Tract Infection (2120)

Event Date 09/09/2015

Event Type  Other  

Event Description

Incident: two painful urinary tract infections (uti) and groin skin rash after using poise microliners (for light bladder leakage protection.Incident dates: (b)(6) 2015 urinary tract infection diagnosed in (b)(6).On (b)(6) 2015 groin skin rash diagnosed at (b)(6) hospital.On (b)(6) 2015 urinary tract infection diagnosed at (b)(6) hospital.I started using these poise liners in (b)(6) 2015 because i was traveling.Women often wear panty liners to feel "fresh." i couldn't understand why i was having so many problems in my genital region.I did some research and found an abstract on nih.Gov website that describes allergic contact dermatitis because the liners rested positive for (eth) acrylates.Here is the link to the abstract: hhtp://www.Ncbi.Nlm.Nih.Gov/pubmed/12165934.Retailer: (b)(6).Purchase date: 09/01/2015.The product was not damaged before the incident.The product was not modified before the incident.(b)(4).

• Brand Name: POISE
• Type of Device: POISE MICROLINES (LIGHT BLADDER LEAKAGE PROTECTION)
• Manufacturer (Section D): KIMBERLY-CLARK GLOBALSALES, LLC; po box 2020; dept. pmll-50; neenah WI 54957
• MDR Report Key: 5311045
• MDR Text Key: 34002021
• Report Number: MW5058588
• 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: 12/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: POISE MICROLINERS
• Other Device ID Number: BJ523306X2105 N17
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR