MAUDE Adverse Event Report: COOPERSURGICAL, INC. RING W/SUPP #4 70MM

Model Number MXPRS04

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Rash (2033)

Event Date 12/22/2022

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Details reported are as follows: "very itchy red patches on the inner thighs due to vaginal discharge created by the pessary.Removal of the pessary in the care facility and immediate improvement.Silicone may be involved." ring w supp no 4 70mm (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 10/226/2022 under wo #324430.Manufacturing record review: dhr 324430 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: not applicable.Historical complaint review: a review of the 2-year complaint history showed one similar reported complaint condition.Product receipt: the complaint unit was not returned to coopersurgical.Visual evaluation: a visual evaluation could not be completed as the complaint unit has not been returned to coopersurgical.Functional evaluation: an evaluation could not be completed as the complaint unit has not been returned to coopersurgical.Root cause: no definitive root cause for this issue could be reliably determined as the complaint unit was not returned.Note: the pessary product family has been biologically tested and on report ber-td082-001 documenting acceptable results compliant to the appropriate eu regulations.Correction and/or corrective action no additional record of returns for this lot was noted in the system.Additionally, no other units from this lot was available to evaluate.No further corrective action is necessary, as the complaint condition was not confirmed.No training is required.Was the complaint confirmed? no.Preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Details reported are as follows: "very itchy red patches on the inner thighs due to vaginal discharge created by the pessary.Removal of the pessary in the care facility and immediate improvement.Silicone may be involved." 1216677-2023-00048 ring w supp no 4 70mm (b)(4).

• Brand Name: RING W/SUPP #4 70MM
• Type of Device: RING W/SUPP #4 70MM
• 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 corpoarte dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 16522650
• MDR Text Key: 311220879
• Report Number: 1216677-2023-00048
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

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: MXPRS04
• Device Catalogue Number: MXPRS04
• Device Lot Number: 324430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 05/17/2023
• 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