MAUDE Adverse Event Report: COOPERSURGICAL, INC. RING W/SUPP #4 70MM

Model Number MXKPRS04

Device Problems Material Puncture/Hole (1504); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currenlty investigating the reported condition.

Event Description

Report stated "the circumference of the ring presents several little holes, irregularities, roughness, in their original unused condition.These irregularities appear to be likely to create irritation of the vaginal walls, and to retain bacteria." per follow-up response- there was patient involvement - for the first pessary, no for the second one.The patient spotted the defect through the plastic bag and chose not to open it.Was there any adverse effect as a result of reported condition? if yes what adverse event ? not that we know of, the first pessary has been used for a few days only, and the second one has not been used.As there any additional medical attention as a result of the reported condition? kit-ring w-supp no 4 70mm mxprs04 (b)(4).

Event Description

Report stated "the circumference of the ring presents several little holes, irregularities, roughness, in their original unused condition.These irregularities appear to be likely to create irritation of the vaginal walls, and to retain bacteria." per follow-up response- there was patient involvement - for the first pessary, no for the second one.The patient spotted the defect through the plastic bag and chose not to open it.*was there any adverse effect as a result of reported condition? if yes what adverse event ? not that we know of, the first pessary has been used for a few days only, and the second one has not been used *was there any additional medical attention as a result of the reported condition? no 1216677-2021-00172 kit-ring w-supp no 4 70mm mxprs04 (b)(4).

Manufacturer Narrative

Investigation x-no sample returned x-review dhr *analysis and findings (b)(4).*was the complaint confirmed? no distribution history the complaint product was manufactured at csi in february 2021 under work order (b)(4).Manufacturing record review dhr21mpg000845 was reviewed and no non-conformities, related to the complaint condition, were noted.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 visual examination of the complaint product could not be completed as the product has not been returned.The complainant did provide pictures and the outside diameter of the product may have some irregularities.However, without a physical sample to review, it is difficult to determine this.Functional 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 after the rings are molded, the subsequent operation buffs the outside diameter to remove excess material.Should the buffing operation remove too much material, the secondary operation will apply silicone to fill in the gaps.Without the physical sample to review, the complainant pictures are not clear enough to determine if the silicone was applied properly.*correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.No training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: RING W/SUPP #4 70MM
• Type of Device: RING W/SUPP #4 70MM
• 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 ; 4752651665
• MDR Report Key: 12540999
• MDR Text Key: 274487323
• Report Number: 1216677-2021-00172
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/20/2021

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: MXKPRS04
• Device Catalogue Number: MXKPRS04
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2023
• 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