MAUDE Adverse Event Report: COOPERSURGICAL, INC. FITTING,RING-SIZE#5 76MM

Model Number MXFIT0023

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Hypersensitivity/Allergic reaction (1907); Urticaria (2278)

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currently investigating the reported condition.

Event Description

Incident details surrounding event we received a report from a doctor in the department of obstetrics and gynecology at (b)(6) hospital.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.Per report-patient status fever from allergy.Fitting, ring-size#5 76mm mxfit0023.E-complaint (b)(4).

Manufacturer Narrative

Investigation: x-no sample returned.Analysis and findings: e-complaint: (b)(4).Was the complaint confirmed? no.Distribution history: the complainant did not report the lot number thus the distribution history cannot be obtained at this time.Should the complaint product lot number be provided going forward, the distribution history will be reviewed, and this complaint amended accordingly.Manufacturing record review: a review of the device history record could not be performed because the lot number were 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 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; root cause not applicable as the complaint condition was not confirmed.Correction and/or corrective action: coopersurgical will continue to monitor this complaint condition for trends.No further corrective action is necessary, as the complaint condition was not confirmed.Preventative action activity: coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Incident details surrounding event: we received a report from a doctor in the department of obstetrics and gynecology at (b)(6) hospital.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.Per report-patient status fever from allergy.1216677-2021-00216 fitting, ring-size#5 76mm mxfit0023 e-complaint: (b)(4).

• Brand Name: FITTING,RING-SIZE#5 76MM
• Type of Device: FITTING,RING-SIZE#5 76MM
• 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 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 12584506
• MDR Text Key: 278170775
• Report Number: 1216677-2021-00216
• Device Sequence Number: 1
• Product Code: HHW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/05/2021

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: MXFIT0023
• Device Catalogue Number: MXFIT0023
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 04/20/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other