MAUDE Adverse Event Report: COOPERSURGICAL, INC. WALLACE RING PESSARY

Model Number WALLACE RING PESSARY

Device Problem Difficult to Remove (1528)

Patient Problem Adhesion(s) (1695)

Event Date 04/08/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currenlty investigating the reported condition.

Event Description

There is adhesion of ring pessary and unable to remove it from the patient even using a pessary cutter.This incident happened around late march.The duration of the pessary is to be confirmed.1216677-2022-00118 wallace ring pessary e-complaint-(b)(4).

Manufacturer Narrative

The product was not returned, therefore no hands-on investigation was able to be completed.The lot number was unknown so a dhr review was not able to be completed.A review of the 2-year complaint history did not show similar reported complaint conditions.Medical affairs was made aware and is working with the physician to resolve the pessary removal issue.The following additional information was requested: who placed the pessary? when was it placed/how long has it been there? what exactly was placed - pessary type, number, color, size? the response from the customer was "unknown" to all follow-up questions.

Event Description

There is adhesion of ring pessary and unable to remove it from the patient even using a pessary cutter.This incident happened around late march.The duration of the pessary is to be confirmed.1216677-2022-00118-1, wallace ring pessary, e-complaint-(b)(4).

• Brand Name: WALLACE RING PESSARY
• Type of Device: WALLACE RING PESSARY
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 14180689
• MDR Text Key: 297432086
• Report Number: 1216677-2022-00118
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K904774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WALLACE RING PESSARY
• Device Catalogue Number: WALLACE RING PESSARY
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other