MAUDE Adverse Event Report: COOPERSURGICAL, INC. GELLHORN 95% RIGID 2-1/2

Model Number MXPGRS2-1/2

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currenlty investigating the reported condition.

Event Description

Incident details surrounding event pessary is too rigid to use.Response as follows- did the incident occur before, during, or after a procedure? before.Patient, gamete, embryo, or end user involvement? yes.Any patient injury or impact to the gamete or embryo? no.Medical or procedural intervention? yes.Patient/gamete/embryo status.At least 2 pessaries were thrown out.I have 4 left in the package.Approximately 3 days following.This is the 4th time completing the removal and reinsertion process, this has occurred each time.Last visit to physician was (b)(6) 2020.Gellhorn 95% rigid 2-1/2 mxpgrs2-1/2.E-complaint (b)(4).

Event Description

Incident details surrounding event pessary is too rigid to use.Response as follows- did the incident occur before, during, or after a procedure? before.Patient, gamete, embryo, or end user involvement? yes.Any patient injury or impact to the gamete or embryo? no.Medical or procedural intervention? yes.Patient/gamete/embryo status.At least 2 pessaries were thrown out.I have 4 left in the package.Roximately 3 days following.This is the 4th time completing the removal and reinsertion process, this has occurred each time.Last visit to physician was on (b)(6) 2020.1216677-2021-00179 gellhorn 95% rigid 2-1/2 mxpgrs2-1/2 (b)(4).

Manufacturer Narrative

Investigation: x-no sample returned x-review dhr.*analysis and findings (b)(4).*was the complaint confirmed? no.Distribution history the complaint product was manufactured at csi on 04/06/2020 under work order (b)(4).Manufacturing record review dhr (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 did not show similar reported complaint conditions.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 root cause not applicable as the complaint condition was not confirmed.*correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.No further training required at this time.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: GELLHORN 95% RIGID 2-1/2
• Type of Device: GELLHORN 95% RIGID 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: 12369590
• MDR Text Key: 270663147
• Report Number: 1216677-2021-00179
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2021

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: MXPGRS2-1/2
• Device Catalogue Number: MXPGRS2-1/2
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other