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

Model Number MXPGE2-1/2

Device Problem Output Problem (3005)

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

Event Date 04/20/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currenlty investigating the reported condition.

Event Description

Incident details surrounding event the end user is confident these pessaries are the remainder from an original po from several months ago.We identified an issue with pessary production that was causing increased stiffness with our pessaries.The client is looking for a credit.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? no.Patient/gamete/embryo status patient was not harmed.The nursing staff identified the stiffness issue and removed the pessaries from their stock.Is this an isolated or ongoing event (if ongoing, please provide separate reports for each event)? i believe this to be an isolated event.We identified months ago the issue within the production of the pessaries.1216677-2022-00155 gellhorn pess flex 2-1 2 mxpge2-1 2 e-complaint-(b)(4).

Manufacturer Narrative

Investigation.X-initiated manufacturer's investigation.X-no sample returned.X-review dhr.Analysis and findings.Distribution history.The complaint product was manufactured at csi on 9-30-20 under work order (b)(4).Manufacturing record review.Dhr-293432 was reviewed and no non-conformities, related to the complaint condition, were noted.This work order was completed before the durometer specification of this product was reduced from 60 to 45 on ecn-23808.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 showed similar reported complaint conditions.There are additional complaints for the same issue from product manufactured in the same timeline prior to ecn-23808.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.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.Correction and/or corrective action.This issue has been addressed by ecn-23808.Coopersurgical will continue to monitor this complaint condition for any trends.Corrective action level 1 2 3 4.Train personnel.None.Reason: no further training required at this time.Was the complaint confirmed? yes no.

Event Description

Incident details surrounding event the end user is confident these pessaries are the remainder from an original po from several months ago.We identified an issue with pessary production that was causing increased stiffness with our pessaries.The client is looking for a credit.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? no.Patient/gamete/embryo status.Patient was not harmed.The nursing staff identified the stiffness issue and removed the pessaries from their stock.Is this an isolated or ongoing event (if ongoing, please provide separate reports for each event)? i believe this to be an isolated event.We identified months ago the issue within the production of the pessaries.1216677-2022-00155 gellhorn pess flex 2-1 2 mxpge2-1 2 e-complaint-(b)(4).

• 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: 14521572
• MDR Text Key: 298478355
• Report Number: 1216677-2022-00155
• Device Sequence Number: 1
• Product Code: HHW
• 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: Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

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: 05/27/2022
• Supplement Dates Manufacturer Received: 05/02/2022
• Supplement Dates FDA Received: 08/05/2022
• 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