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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. RING W/SUPP. #1
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COOPERSURGICAL, INC. RING W/SUPP. #1 Back to Search Results
Model Number MXPRS01
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2019
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.Ref: (b)(4).
 
Event Description
Per phone conversation.Patient reported that she has tried different sizes.First a size-2- than a size -1-, and now using size 0.She believes she may need a size between the standard sizes.However, the physician did not utilize a sizing kit before prescribing.Ref (b)(4).
 
Event Description
Per phone conversation.Patient reported that she has tried different sizes.First a size-2- than a size -1-, and now using size 0.She believes she may need a size between the standard sizes.However, the physician did not utilize a sizing kit before prescribing.Ref e-complaint (b)(4).
 
Manufacturer Narrative
Ref: (b)(4).Investigation: x-no sample returned, x-review dhr.Analysis and findings: distribution history.The complaint product was manufactured at csi in november 2018 under work order (b)(4).Manufacturing record review: dhr-mxprs01-240549 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: 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 referencing the attached letter from sandy maini, coopersurgical paralegal dated 3/20/20: "csi does not manufacture and sell a "1 1/2 size." nor does csi manufacture or sell a "1/2 size." the fact that csi does not sell pessaries in those sizes does not mean the pessaries it sells are "missized." for example, a size 1 pessary sold by csi is a size 1.The selection of the size of a pessary for the patient and the fitting of it is performed by your physician.We suggest you discuss any concerns you may have about size selection or fit with your physician." correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.Preventative action activity: coopersurgical will continue to monitor this complaint condition for any trends.
 
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Brand Name
RING W/SUPP. #1
Type of Device
RING W/SUPP. #1
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull, ct CT 06611
MDR Report Key9676863
MDR Text Key191403342
Report Number1216677-2020-00031
Device Sequence Number1
Product Code HHW
Combination Product (y/n)N
PMA/PMN Number
K904774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 05/22/2020
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 Expiration Date11/01/2023
Device Model NumberMXPRS01
Device Catalogue NumberMXPRS01
Device Lot Number240549
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/04/2020
Initial Date FDA Received02/06/2020
Supplement Dates Manufacturer Received02/04/2020
Supplement Dates FDA Received05/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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