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

Model Number WALLACE RING PESSARY

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/05/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

There is adhesion of ring pessary, and the doctor will try to extract the pessary by pessary cutter hereafter.The patient visits the hospital once in 3 weeks for routine checkup.Wallace ring pessary e-complaint- (b)(4).

Event Description

There is adhesion of ring pessary, and the doctor will try to extract the pessary by pessary cutter hereafter.The patient visits the hospital once in 3 weeks for routine checkup.1216677-2022-00208 wallace ring pessary (b)(4).

Manufacturer Narrative

Investigation: x-no sample returned.*analysis and findings: distribution history no product reference code or lot number was provided, distribution history could not be determined.Manufacturing record review: a review of the device history record could not be performed because the lot/serial number was not provided.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the complaint product lot/serial number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.Incoming inspection review: incoming inspection record review not applicable to this product.Service history record : service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation : evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause : the complaint condition was not confirmed as no product was returned.Follow-up was completed by product surveillance for part number and lot number.No further details were attained.Additional correspondence was received that the pessary was removed in (b)(6) 2022 and that the patient has recovered.If any further information is received, the complaint will be amended.*correction and/or corrective action: no further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.*preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: WALLACE RING PESSARY
• Type of Device: WALLACE RING PESSARY
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 15083812
• MDR Text Key: 304132015
• Report Number: 1216677-2022-00208
• 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: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 07/10/2022
• Supplement Dates FDA Received: 01/04/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other