MAUDE Adverse Event Report: KIMBERLY CLARK INCONTINENCE PADS POISE BLADDER LEAKAGE PROTECTION

Catalog Number ALL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Itching Sensation (1943); Pain (1994); Skin Irritation (2076)

Event Date 11/23/2014

Event Type  Injury  

Event Description

I've used poise bladder protection pads since 2006 or 2007, but it wasn't until they changed them with the same technology that i began to experience horrible pain, irritation and itching.My last gynecologist appointment, i was diagnosed with bacterial vaginosis, and treated.I thought that would be the end of the itching-nope! i am in daily agony, and now that i've made this connection, i'm going to have to change products unless kimberly clark goes back to their old pads.

• Brand Name: INCONTINENCE PADS POISE BLADDER LEAKAGE PROTECTION
• Type of Device: INCONTINENCE PADS POISE BLADDER LEAKAGE PROTECTION
• Manufacturer (Section D): KIMBERLY CLARK
• MDR Report Key: 4284335
• MDR Text Key: 18919933
• Report Number: MW5039284
• 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: 11/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: ALL
• Device Lot Number: POISE LIGHT LEAKAGE PADS
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 51