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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. PESSARY
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COOPERSURGICAL, INC. PESSARY Back to Search Results
Model Number UNKNOWN
Device Problem Defective Device (2588)
Patient Problems Abrasion (1689); Hemorrhage/Bleeding (1888); Tissue Damage (2104)
Event Date 03/31/2020
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc.Is currently investigating the reported complaint condition.
 
Event Description
End user called in to report claimed defective pessary.She stated pessary did not hold up, experienced bleeding on removal as well as some tissues came off with device in this process.Further stated the edge of the ring was rusted thus causing abrasion.End-user advised to have her practice call in to provide details of product in question since those information were not readily available.End-user will advise once all information to support report is ready.(b)(4).
 
Manufacturer Narrative
Investigation: x-no sample returned.Analysis and findings: (b)(4).Distribution history: the lot number was not reported by the customer.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 did not show similar reported complaint conditions for the entire ring pessary family.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: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.Review and closure: fault code: no fault.Failure code: could not reliably be determined.Preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.
 
Event Description
End user called in to report claimed defective pessary.She stated pessary did not hold up, experienced bleeding on removal as well as some tissues came off with device in this process.Further stated the edge of the ring was rusted thus causing abrasion.End-user advised to have her practice call in to provide details of product in question since those information were not readily available.End-user will advise once all information to support report is ready.(b)(4).
 
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Brand Name
PESSARY
Type of Device
PESSARY
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull, ct
MDR Report Key9941657
MDR Text Key191430795
Report Number1216677-2020-00091
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
Type of Report Initial,Followup
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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