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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. INCONT DISH W/SP-65MM #2

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COOPERSURGICAL, INC. INCONT DISH W/SP-65MM #2 Back to Search Results
Model Number MXPCONDS02
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/05/2019
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.Once the investigation is complete, a follow up report will be filed.(b)(4).
 
Event Description
Complainant ordered another pessary, which was even larger than the first replacement, though it was also marked 70mm.It also made the patient bleed.
 
Manufacturer Narrative
It has been approximately 50 days and the reported sample has not been returned for investigative analysis.This product is molded and packaged at coopersurgical.A review of two year complaint history shows no complaints.The reported complaint did not furnish a lot number.A sampling of current finished goods inventory did not find any mixed product.It should be noted that as part of the bagging process: prior to placing in the bag, each piece is 100% inspected for size by a vision system.There have not been any recent changes to process or specifications.The reported complaint could not be confirmed.
 
Event Description
Complainant ordered another pessary, which was even larger than the first replacement, though it was also marked 70mm.It also made the patient bleed.1216677-2019-00135-1 incont dish w-sp-65mm-2 mxpconds02 (b)(4).
 
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Brand Name
INCONT DISH W/SP-65MM #2
Type of Device
INCONT DISH W/SP-65MM #2
Manufacturer (Section D)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer (Section G)
COOPER SURGICAL, INC
95 corporate drive
trumbull CT 06611
Manufacturer Contact
michael marone
50 corporate drive
trumbull, CT 06611
4752651665
MDR Report Key8448869
MDR Text Key139819872
Report Number1216677-2019-00135
Device Sequence Number1
Product Code HHW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K904774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model NumberMXPCONDS02
Device Catalogue NumberMXPCONDS02
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/12/2019
Initial Date FDA Received03/25/2019
Supplement Dates Manufacturer Received03/07/2019
Supplement Dates FDA Received04/18/2023
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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