MAUDE Adverse Event Report: COOPERSURGICAL, INC. CUBE PESSARY W/HOLES #1

Model Number MXPECH01

Device Problem Break (1069)

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

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

Cooper surgical, inc.Is currently investigating the reported condition.

Event Description

Report stated, "the pessary cordon broke after a few days of use, and the patient had to go to medical emergencies to remove the pessary.This patient was used to wear a cube pessary from another manufacturer.She had been wearing this competitor cube pessary for one year before buying the milex cube, so she knew how to use a cube pessary." ref#: (b)(4).(b)(4).

Manufacturer Narrative

Investigation: x-no sample returned: x-review dhr.Analysis and findings: was the complaint confirmed? no.Distribution history: the complaint product was manufactured at csi in march 2020 under work order (b)(4).Manufacturing record review: dhr20mpg001955 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 showed one other similar reported complaint condition.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: according to the ifu, the cord is meant to be used as a guide for locating the pessary only and should not be pulled on to remove the pessary (see attachment).Based on the complaint report, it is suspected the user mistakenly used the cord to remove the pessary which caused it to detach.Correction and/or corrective action: no further corrective action is necessary, as the complaint condition was not confirmed.No training required at this time.Preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.This report is being submitted as part of a retrospective review of our reportable events, which occurred in 2020.

Event Description

Report stated "the pessary cordon broke after a few days of use, and the patient had to go to medical emergencies to remove the pessary.This patient was used to wear a cube pessary from another manufacturer.She had been wearing this competitor cube pessary for one year before buying the milex cube, so she knew how to use a cube pessary.Ref e-complaint: (b)(4).1216677-2020-00240.Cube pessary w-holes no 1 mxpech01 e-complaint: (b)(4).

• Brand Name: CUBE PESSARY W/HOLES #1
• Type of Device: CUBE PESSARY W/HOLES #1
• 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 dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 10711089
• MDR Text Key: 214801312
• Report Number: 1216677-2020-00240
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/21/2020

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: MXPECH01
• Device Catalogue Number: MXPECH01
• Device Lot Number: 282894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 05/10/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other