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U.S. Department of Health and Human Services

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

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COOPERSURGICAL, INC. RING W/SUPP #4 70MM Back to Search Results
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.
 
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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 Key12540999
MDR Text Key274487323
Report Number1216677-2021-00172
Device Sequence Number1
Product Code HHW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K904774
Number of Events Reported1
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 NumberMXKPRS04
Device Catalogue NumberMXKPRS04
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/28/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/06/2023
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 Number1
Patient Outcome(s) Other;
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