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U.S. Department of Health and Human Services

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

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COOPERSURGICAL, INC. RING W/SUPP #4 70MM Back to Search Results
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).
 
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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 Key16522650
MDR Text Key311220879
Report Number1216677-2023-00048
Device Sequence Number1
Product Code HHW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K904774
Number of Events Reported1
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 NumberMXPRS04
Device Catalogue NumberMXPRS04
Device Lot Number324430
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/24/2023
Initial Date FDA Received03/10/2023
Supplement Dates Manufacturer Received02/24/2023
Supplement Dates FDA Received05/17/2023
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 Number1
Patient Outcome(s) Other;
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