MAUDE Adverse Event Report: COOPERSURGICAL, INC. PESS.SH.STEM FLEX 2-1/4

Model Number	MXPGSS2-1/4
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 currently investigating the condition reported.
Event or Problem Description
(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.1216677-2020-00269 pess sh stem flex 2-1 4 mxpgss2-1 4 e-complaint-(b)(4).
Additional Manufacturer Narrative
Initiated manufacturer's investigation: no sample returned.Review dhr: inspect stock product.Distribution history: the complaint product was manufactured at csi in march 2020 under work order: (b)(4).Manufacturing record review: dhr20mpg002518 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 other 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.Corrective actions: coopersurgical decided to return manufacturing to the supplier (eis) in late 2020.Long stem gellhorns were qualified per val-20-0285 and short stem gellhorn pessaries were qualified per val-20-0289.In addition, the prints for the gellhorn pessaries were updated to reduce the durometer hardness from 60 to 45.Was the complaint confirmed? no.
Event or Problem Description
Report stated: "the customer has issued a customer dissatisfaction complaint some time ago saying the pessaries are too stiff".1216677-2020-00269-1 mxpgss2-1/4 pess.Sh.Stem flex 2-1/4 e-complaint: (b)(4).

• Brand Name: PESS.SH.STEM FLEX 2-1/4
• Common Device Name: PESS.SH.STEM FLEX 2-1/4
• 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: 10881796
• Report Number: 1216677-2020-00269
• Device Sequence Number: 2884964
• Product Code: HHW
• UDI-Device Identifier: 00888937007497
• UDI-Public: 888937007497
• 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): 02/08/2023

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: MXPGSS2-1/4
• Device Catalogue Number: MXPGSS2-1/4
• Device Lot Number: 263394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 11/22/2020
• Supplement Report FDA Received Date: 02/08/2023
• 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