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

Model Number MXPDO07

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currenlty investigating the reported conditon.

Event 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).

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 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
• Type of Device: 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
• MDR Text Key: 245332916
• Report Number: 1216677-2020-00272
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00888937004991
• UDI-Public: 888937004991
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K904774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other