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

Model Number	MXPGE2-1/4
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 currenlty investigating the reported condition.
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.Additional complaint in ref.To e-complaint-(b)(4).1216677-2020-00273 gellhorn pess flex 2-1 4 mxpge2-1 2 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 january 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 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.*correction and/or corrective action.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
The pessary is too stiff.Gellhorn pess flex 2 1-4 mxpge2 1-4 e-complaint-(b)(4).

• Brand Name: GELLHORN PESS.FLEX.2-1/4
• Common Device Name: GELLHORN PESS.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: 10881831
• Report Number: 1216677-2020-00273
• Device Sequence Number: 16865102
• Product Code: HHW
• UDI-Device Identifier: 00888937006711
• UDI-Public: 888937006711
• 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,Distributor
• 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: MXPGE2-1/4
• Device Catalogue Number: MXPGE2-1/4
• Device Lot Number: 276280
• 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: 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