MAUDE Adverse Event Report: COOPERSURGICAL, INC. DONUT PESS 2-3/4 IN #3

Model Number MXPDO03

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

Cooper surgical, inc.Is currently investigating the condition reported.

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).1216677-2020-00275 donut pess 2-3 4 in no 3 mxpdo03 (b)(4).

Manufacturer Narrative

Clarification to h.6.Component code: the unit is a donut-shaped pessary and the complaint is against the material stiffness.Investigation: distribution history the complaint product was manufactured at csi in (b)(6) 2020 under work order (b)(4).Manufacturing record review (b)(6) 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 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 until mid-2017.Manufacturing was moved to coopersurgical and validated in (b)(6) 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 per 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.

Event Description

Company representative reported "the customer has issued a customer dissatisfaction complaint some time ago saying the pessaries are too stiff." (b)(4).

• Brand Name: DONUT PESS 2-3/4 IN #3
• Type of Device: DONUT PESS 2-3/4 IN #3
• 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 ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 10904554
• MDR Text Key: 221012165
• Report Number: 1216677-2020-00275
• Device Sequence Number: 1
• Product Code: HHW
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

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: MXPDO03
• Device Catalogue Number: MXPDO03
• Device Lot Number: 262774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2020
• 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