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

Model Number WALLACE RING PESSAEY

Device Problems Difficult to Remove (1528); Output Problem (3005)

Patient Problems Hemorrhage/Bleeding (1888); Ulcer (2274)

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Report submitted by csi (b)(4)- exact part number is unknown-described as -wallace ring pessary.Incident detail- despite having a regular checkup every two to three months, an ulceration and bleeding were occurred a month later after the checkup.Additional info- before the event happened, the doctor rotates wrp to disperse the vaginal pressure for the patient whose wrp cannot be easily removed from.Wallace ring pessary (b)(4).

Manufacturer Narrative

Investigation: x-initiated manufacturer's investigation x-no sample returned.Analysis and findings distribution history the product reference and lot numbers were not reported by the customer, therefore a distribution history search was not possible.Manufacturing record review: a review of the device history record could not be performed because the lot 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 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 for the entire wallace ring pessary family showed one similar complaint.There is one additional instance of reported bleeding associated with use of a wallace ring pessary.The root cause could not be determined.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation / 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: no definitive root cause for this issue could be reliably determined at this time, *correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.Reason: no further training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Report submitted by csi japan- exact part number is unknown-described as -wallace ring pessary.Incident detail- despite having a regular checkup every two to three months, an ulceration and bleeding were occurred a month later after the checkup.Additional info- before the event happened, the doctor rotates wrp to disperse the vaginal pressure for the patient whose wrp cannot be easily removed from.1216677-2022-00057 wallace ring pessary (b)(4).

• 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: 13664646
• MDR Text Key: 289255263
• Report Number: 1216677-2022-00057
• 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: 02/26/2022

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 PESSAEY
• 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: 02/04/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: No
• 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