MAUDE Adverse Event Report: COOPERSURGICAL, INC. DONUT PESS 3-1/4 IN #5

Model Number MXPDO05

Device Problems Crack (1135); Material Integrity Problem (2978)

Patient Problem Abrasion (1689)

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

The pessary did not present any visible anomalies at the time it was acquired, it was only strange its rigidity and hardness, it was very hard and not so flexible for its manipulation, it had been placed and removed on 4 previous occasions.On (b)(6), when the pessary was being placed in my grandmother, she felt as if she was being pinched inside the vaginal canal so we proceeded to remove it again, she said she felt that something cracked inside and bled so when she looked at the pessary it was cracked on one side and when she pressed it again it cracked even more when she pretended to put it back in.Donut pess 3-1/4 in #5 mxpdo05 (b)(4).

Manufacturer Narrative

Investigation no sample returned review dhr *analysis and findings (b)(4).Distribution history: this complaint unit was manufactured at csi on 9/16/2021.Manufacturing record review: dhr 310466 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: n/a.Historical complaint review: a review of the 2-year complaint history showed one similar reported complaint condition specifically for stiff pessaries in late 2020.No product was returned, hence the complaint was not confirmed.A review confirmed the process was validated and noted prints were up to date.No issues were found in the review of the process or the material.Product receipt: the complaint unit was processed for return via rma 337880.However, the unit has not been received as of 12/20/2022.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: a review of the print confirms there is no record of a change on the durometer.The process had been moved to coopersurgical in 2017 away from the previous manufacturer and validated under val-16-0219 using a new silicone supplier.It has been observed the silicone produced since 2017 is slightly harder, but not significant as the durometer is within specification and certified tested by the vendor per astm d2240.*correction and/or corrective action a review of same lot (#310466) units was not possible as the last unit from the lot was shipped in april of 2022.The process was reviewed and found to have sufficient guidance on handling reject parts.As the unit was not returned for an evaluation a root cause is not determinable to correspond with a corrective action.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary.No training required at this time.*was the complaint confirmed? no.

Event Description

The pessary did not present any visible anomalies at the time it was acquired, it was only strange its rigidity and hardness, it was very hard and not so flexible for its manipulation, it had been placed and removed on 4 previous occasions.On august 29, when the pessary was being placed in my grandmother, she felt as if she was being pinched inside the vaginal canal so we proceeded to remove it again, she said she felt that something cracked inside and bled so when she looked at the pessary it was cracked on one side and when she pressed it again it cracked even more when she pretended to put it back in.Donut pess 314 in 5 mxpdo05 (b)(4).

• Brand Name: DONUT PESS 3-1/4 IN #5
• Type of Device: DONUT PESS 3-1/4 IN #5
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 15712677
• MDR Text Key: 307281330
• Report Number: 1216677-2022-00290
• Device Sequence Number: 1
• Product Code: HHW
• UDI-Device Identifier: 88937004977
• UDI-Public: 88937004977
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K904774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

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: MXPDO05
• Device Catalogue Number: MXPDO05
• Device Lot Number: 310466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 10/05/2022
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• 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