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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. DONUT PESS 3-1/4 IN #5

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COOPERSURGICAL, INC. DONUT PESS 3-1/4 IN #5 Back to Search Results
Model Number MXPDO05
Device Problem Material Too Rigid or Stiff (1544)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2020
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical, inc.Is currently investigating the reported condition.
 
Event Description
E-complaint: (b)(4).Report forwarded by customer service trumbull- the customer has issued a customer dissatisfaction complaint some time ago saying the pessaries are too stiff.Additional complaint in ref.To e-complaint: (b)(4).Donut pess 3-1 4 in no 5 mxpdo05 e-complaint: (b)(4).
 
Event Description
Healthcare professional reported "the pessaries are too stiff.".
 
Manufacturer Narrative
Clarification to h6.Component code: unit is a one-piece pessary, and the complaint is against the rigidity/stiffness of the material.Investigation findings: distribution history: the complaint product was manufactured at csi in march 2020.Manufacturing record review: the device history record was reviewed, and no non-conformities related to the complaint condition, were noted.Historical complaint review: a review of the 2-year complaint history shows one other complaint for this issue.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: quality engineering, manufacturing, marketing, and product surveillance conducted an investigation into the recent complaints regarding the hardness and rigidity of the pessary product line.There were no specification changes in the last 2 years.Returned product from historical complaint investigations and sample product from finished goods inventory were evaluated and the reported condition could not be duplicated.The products were found to meet all approved released specifications.It should be noted that this product was originally manufactured for coopersurgical by a supplier (eis) until mid-2017.Manufacturing was moved to coopersurgical and validated in november 2017 using a new silicone supplier.It is suspected the customer noticed the current production pessary was slightly harder than the previously received supplier pessary.It should also be noted that the current silicone supplier provides certifications on every shipment with durometer hardness testing which verifies durometer specifications are met.Based upon an analysis of historical returned/complaint product, stock product, dhr review and certificates of conformance, the reported complaint condition could not be confirmed.Corrective action: a capa was opened to determine if customer observations with regard to pessary durometer warrant further product enhancements.
 
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Brand Name
DONUT PESS 3-1/4 IN #5
Type of Device
DONUT PESS 3-1/4 IN #5
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull CT 06611
Manufacturer (Section G)
COOPERSURGICAL, INC.
95 corporate drive
trumbull CT 06611
Manufacturer Contact
michael marone
50 corporate drive
trumbull, CT 06611
2036015200
MDR Report Key10915101
MDR Text Key222704608
Report Number1216677-2020-00276
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/05/2023
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 NumberMXPDO05
Device Catalogue NumberMXPDO05
Device Lot Number267900
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/13/2020
Initial Date FDA Received11/27/2020
Supplement Dates Manufacturer Received11/13/2020
Supplement Dates FDA Received05/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2020
Is the Device Single Use? 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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