MAUDE Adverse Event Report: KIMBERLY-CLARK CORPORATION POISE IMPRESS; PESSARY, VAGINAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Incontinence (1928)

Event Date 05/10/2019

Event Type  Injury  

Event Description

The pt inserted a poise impress device approx 2 years ago to self-treat urinary incontinence.She never removed the device.She then presented for care for constant urinary leakage and was noted to have the device in her vagina and a vesico-vaginal fistula.Of note, there is a picture of the explanted device in the pt's emr, but i do not have a copy of the image file.Fda safety report id# (b)(4).

• Brand Name: POISE IMPRESS
• Type of Device: PESSARY, VAGINAL
• Manufacturer (Section D): KIMBERLY-CLARK CORPORATION; neenah WI 54956
• MDR Report Key: 8790652
• MDR Text Key: 151196265
• Report Number: MW5088098
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 72 YR
• Patient Weight: 73