MAUDE Adverse Event Report: COOPERSURGICAL, INC. DONUT PESS 3-3/4 IN #7

Model Number	MXPDO07
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Coopersurgical, inc.Is currenlty investigating the reported conditon.
Event or Problem Description
Ref 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 3-3 4 in no 7 mxpdo07 e-complaint (b)(4).
Additional Manufacturer Narrative
Investigation: initiated manufacturer's investigation: no sample returned review dhr inspect stock product.Analysis and findings: distribution history the complaint product was manufactured at csi in february 2020 under work order (b)(4).Manufacturing record review: (b)(4) 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 shows no complaints 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.Correction and/or corrective action: capa 735 has been opened to determine if customer observations with regard to pessary durometer warrant further product enhancements.Was the complaint confirmed? no.
Event or Problem Description
The pessary is too stiff.Donut pess 3 3-4 in 7 mxpdo07 (b)(4).

• Brand Name: DONUT PESS 3-3/4 IN #7
• Common Device Name: DONUT PESS 3-3/4 IN #7
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 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 ; 4752651665
• MDR Report Key: 10886062
• Report Number: 1216677-2020-00272
• Device Sequence Number: 2884966
• Product Code: HHW
• UDI-Device Identifier: 00888937004991
• UDI-Public: 888937004991
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K904774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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
• Operator of Device: Health Professional
• Device Model Number: MXPDO07
• Device Catalogue Number: MXPDO07
• Device Lot Number: 267913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown