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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Respiratory Distress (2045); Urinary Frequency (2275); Hematuria (2558)

Event Date 01/28/2018

Event Type  Injury  

Event Description

I had been sick for about a week with an upper respiratory infection.I was experiencing stress incontinence and saw an ad for impressa.I purchased a package at the store.When i got home, i inserted the impressa.I sat down in my chair to relax.Within the next 45 minutes, i had a strong coughing attack.I leaned forward while coughing and felt a sharp pain in my vaginal area.I immediately walked to the bathroom and removed the impressa.I urinated and noticed more volume with less control of flow.When i wiped myself, i noticed a slight streaking of blood on the toilet paper.Since that time, i continue to experience increase flow of urine with less control during urination.When coughing, flow of urine is dramatically increased.

• Brand Name: IMPRESSA POISE
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): KIMBERLY CLARK
• MDR Report Key: 7240921
• MDR Text Key: 99122802
• Report Number: MW5075043
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2021
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 132