MAUDE Adverse Event Report: COOPERSURGICAL, INC. MILEX PESSARY

Model Number	MXFIT0023
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: japan.Distribution history: the complaint product was manufactured at csi, however, the lot number was not reported by the complainant.Manufacturing record review a review of the device history record could not be performed because the lot/serial number was not provided.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the complaint product lot/serial number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.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: no definitive root cause for this issue could be reliably determined at this time.However, it should be noted the ifu for the fitting kit 38787-ifu has a warning stating, do not use these pessaries on a patient with a known silicone allergy.Late reporting rational: while conducting an internal retrospective review of our complaint system, it was discovered that an initial report for this complaint had not been successfully submitted.We are submitting this initial/final complaint to rectify the oversight.Coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.
Event or Problem Description
It was reported that the use of milex was discontinued due to fever and allergic reactions of urticaria in the neck and whole body, after the patient trying on the support ring.No additional information was provided.1216677-2023-00087 mxfit0023 ring 76mm (b)(4).

• Brand Name: MILEX PESSARY
• Common Device Name: MILEX PESSARY
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull; VA 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, VA 06611 ; 4752651582
• MDR Report Key: 17005014
• Report Number: 1216677-2023-00087
• Device Sequence Number: 15241439
• Product Code: HHW
• UDI-Device Identifier: 00888937012576
• UDI-Public: (01)00888937012576
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K904026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: MXFIT0023
• Device Catalogue Number: MXFIT0023
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female