MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC FLEXAL; POLYMER PATIENT EXAMINATION GLOVE

Model Number	88TN04L
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
I noticed a hole in a glove after i put it on.Size large.Lot my37aa5b023.Mfg date 2025-02-01.Glove box removed from service.Manufacturer response for polymer patient examination glove, flexal (per site reporter).None at this time.

• Brand Name: FLEXAL
• Common Device Name: POLYMER PATIENT EXAMINATION GLOVE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 22666884
• Report Number: 22666884
• Device Sequence Number: 3677850
• Product Code: LZA
• UDI-Device Identifier: 20885380137133
• UDI-Public: (01)20885380137133
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/21/2025
• Report Date (Section F): 07/21/2025

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 Model Number: 88TN04L
• Device Catalogue Number: 88TN04L
• Device Lot Number: MY37AA5B023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/21/2025