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

Model Number	MXPGE2-1/2
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Clarification to h6 component code: the complaint unit is a gellhorn-shaped pessary.The complaint is against the stiffness of the material as a whole.Investigation findings: the complaint product was manufactured at coopersurgical on 30/sep/2020.The device history record was reviewed, and no non-conformities related to the complaint condition were noted.This work order, however, was completed before the durometer specification of this product was reduced from 60 to 45.A review of the two-year complaint history showed similar reported complaint conditions.There are additional complaints for the same issue from product manufactured in the same timeline prior to corrective action.The complaint product was not returned to coopersurgical, therefore, evaluation of the product could not be completed.Root cause: the root cause of this issue has been attributed to a discrepancy in the appropriate durometer of the material compared to the product purchased from the supplier (eis corporation).Corrective actions: this issue has been addressed via an engineering change.Coopersurgical will continue to monitor this complaint condition for any trends.
Event or Problem Description
Healthcare professional reported via company representative "having stiffness issues with our gellhorns.".

• Brand Name: GELLHORN PESS.FLEX.2-1/2
• Common Device Name: GELLHORN PESS.FLEX.2-1/2
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 17612496
• Report Number: 1216677-2022-00153
• Device Sequence Number: 7446160
• Product Code: HHW
• UDI-Device Identifier: 00888937006728
• UDI-Public: 888937006728
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

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 Expiration Date: 09/09/2025
• Device Model Number: MXPGE2-1/2
• Device Catalogue Number: MXPGE2-1/2
• Device Lot Number: 293432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female