MAUDE Adverse Event Report: KIMBERLY-CLARK CORP POISE IMPRESSA; PESSARY, VAGINAL

Model Number SIZE 1

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682)

Patient Problems Laceration(s) (1946); Pain (1994); Blood Loss (2597)

Event Date 05/06/2020

Event Type  Injury  

Event Description

My urologist suggested i use poise impressa to help with a case of incontinence.I applied ky jelly to the device and inserted per the instructions into my vagina.I experienced considerable pain.I layed down and the pain did not back off.After about 20 minutes, i removed the poise impressa.There was bright pink blood on it.I am assuming it scratched the vaginal wall.Fda safety report id# (b)(4).

• Brand Name: POISE IMPRESSA
• Type of Device: PESSARY, VAGINAL
• Manufacturer (Section D): KIMBERLY-CLARK CORP
• MDR Report Key: 10042804
• MDR Text Key: 190663540
• Report Number: MW5094431
• 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: Patient
• Type of Report: Initial
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2022
• Device Model Number: SIZE 1
• Device Lot Number: NN832771A
• 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: 66 YR
• Patient Weight: 59