MAUDE Adverse Event Report: KIMBERLY-CLARK POISE MICROLINERS; INCONTINENCE PADS

Model Number 500000031084

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Local Reaction (2035); Urinary Tract Infection (2120)

Event Date 12/04/2015

Event Type  Injury  

Event Description

I started using poise microliners for light bladder leakage protection.On (b)(6) 2015, i developed a urinary tract infection while on vacation and saw a doctor in (b)(6).In addition, i also developed a skin reaction the groin area, that required a visit to the dermatologist at the (b)(6) hospital.On (b)(6) 2015, i developed another urinary tract infection that required a doctor's visit to the (b)(6) hospital.I have not had a urinary tract infection in ten years prior to these two events.In my opinion, these two urinary tract infections and groin skin condition were a direct result from using these poise pads daily.Sweating probably increased the allergic reaction.There is an abstract on nih's website that details the allergic reaction a patient suffered from using the same poise pads.Here is the website address for the abstract: http://www.Ncbi.Nlm.Nih.Gov/pubmed/12165934 the offending chemical in these pads is (meth) acrylate.According to the epa's website, "methyl methacrylate is used in the manufacture of resins and plastics.Methyl methacrylate is irritating to the skin, eyes, and mucous membranes in humans.An allergic response to dermal exposure may develop.Respiratory effects have been reported in humans following acute; short term and chronic; long term inhalation exposures.Respiratory symptoms observed following acute exposure x include chest tightness, dyspnea, coughing, wheezing, and reduced peak flow.Neurological symptoms have also been reported in humans following acute exposure to methyl methacrylate.Fetal abnormalities have been reported in animals exposed to methyl methacrylate by injection and inhalation.Epa considers methyl methacrylate not likely to be carcinogenic to humans." here is the link to the epa information: http://www3.Epa.Gov/airtoxics/hlthef/methylme.Html.Please investigate my complaint.Thank you for your time and patience.

• Brand Name: POISE MICROLINERS
• Type of Device: INCONTINENCE PADS
• Manufacturer (Section D): KIMBERLY-CLARK
• MDR Report Key: 5277095
• MDR Text Key: 33236482
• Report Number: MW5058399
• 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: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 500000031084
• Device Lot Number: BJ523306X2105 N17
• Other Device ID Number: 0 36000 44871 9
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 62 YR
• Patient Weight: 86