MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CONVERTORS; GOWN, SURGICAL

Model Number	9575
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Surgical gown had an intact dust cover, but a tear in the sterile blue wrap/paper label making the surgical gown non-sterile.

• Brand Name: CONVERTORS
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 8495185
• Report Number: 8495185
• Device Sequence Number: 19098332
• Product Code: FYA
• UDI-Device Identifier: 10885380153525
• UDI-Public: (01)10885380153525(17)231101(10)18LBJ026
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/28/2019
• Report Date (Section F): 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 9575
• Device Catalogue Number: 9575
• Device Lot Number: 18LBJ026
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/28/2019