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

Model Number MXPGE2-1/2

Device Problem Material Too Rigid or Stiff (1544)

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

Event Date 04/20/2022

Event Type  malfunction  

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 Description

Healthcare professional reported via company representative "having stiffness issues with our gellhorns.".

• Brand Name: GELLHORN PESS.FLEX.2-1/2
• Type of Device: 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
• MDR Text Key: 321847495
• Report Number: 1216677-2022-00153
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 00888937006728
• UDI-Public: 888937006728
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female