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

Model Number	9515
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Three issues with surgical gowns:(1) surgical gown was opened for surgeon to don and he noticed a hole in the mid section of the gown.(2) surgical gown ties are torn (torn from inside and the inside tie broke off).(3) surgical gown is coming apart near the wrist (has a hole in the seam).Two gowns are ref: (b)(4) and lot: 18lwq004; one gown is ref: (b)(4) and lot: 18kbj029.

• Brand Name: CONVERTORS
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 8669752
• Report Number: 8669752
• Device Sequence Number: 245038
• Product Code: FYA
• UDI-Device Identifier: 10885380153563
• UDI-Public: (01)10885380153563(17)231107(10)18LWQ004
• 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): 05/22/2019
• Report Date (Section F): 05/22/2019

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: Health Professional
• Device Model Number: 9515
• Device Catalogue Number: 9515
• Device Lot Number: 18LWQ004
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2019
• 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: 05/22/2019