MAUDE Adverse Event Report: COOPERSURGICAL, INC. CUBE PESSARY W/HOLES #3

Model Number MXPECH03

Device Problem Scratched Material (3020)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Report submitted by distributor on behalf of end-user -"the patient was injured when she took it off.She links her injury to the hard material of the pessary and the sharp angles." cube pessary w-holes -3 mxpech03 e-complaint-(b)(4).

Event Description

Report submitted by distributor on behalf of end-user -"the patient was injured when she took it off.She links her injury to the hard material of the pessary and the sharp angles." 1216677-2021-00156-1 cube pessary w holes 3 mxpech03 e-complaint-(b)(4).

Manufacturer Narrative

Investigation no sample returned review dhr.*analysis and findings distribution history the complaint product was manufactured at csi in january 2021 under work order (b)(4).Manufacturing record review dhr21mpg000862 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.Corrective actions : coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.No training required at this time.*was the complaint confirmed? no.

• Brand Name: CUBE PESSARY W/HOLES #3
• Type of Device: CUBE PESSARY W/HOLES #3
• 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: 12328284
• MDR Text Key: 268203140
• Report Number: 1216677-2021-00156
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MXPECH03
• Device Catalogue Number: MXPECH03
• Device Lot Number: 288049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2021
• 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