MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD; GOWN, ISOLATION, SURGICAL

Model Number	69606
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Halyard disposable isolation gowns have had arms sewn shut.

• Brand Name: HALYARD
• Common Device Name: GOWN, ISOLATION, SURGICAL
• Manufacturer (Section D): O&M HALYARD, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 9081563
• Report Number: 9081563
• Device Sequence Number: 2622398
• Product Code: FYC
• UDI-Device Identifier: 10680651696066
• UDI-Public: (01)10680651696066
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 08/26/2019
• Report Date (Section F): 08/26/2019

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: 69606
• Device Catalogue Number: 69606-01
• Device Lot Number: LC9125
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2019
• 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: 08/26/2019