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

Model Number	39049
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The physician's gown was noted to be misaligned at the seams creating holes in the sterile gown.Operation room team members covered it with a tegaderm and kept working.The integrity of paper gowns is being called into question with multiple issues and recalls.

• Brand Name: CONVERTORS
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 9882725
• Report Number: 9882725
• Device Sequence Number: 19531677
• Product Code: FYA
• UDI-Device Identifier: 10885380108693
• UDI-Public: (01)10885380108693
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2020
• Report Date (Section F): 03/03/2020

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: No Information
• Device Model Number: 39049
• Device Catalogue Number: 39049
• Device Lot Number: 19KBD502
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2020
• 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: 03/03/2020