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

Model Number 69606

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2019

Event Type  malfunction  

Event Description

Halyard disposable isolation gowns have had arms sewn shut.

• Brand Name: HALYARD
• Type of Device: GOWN, ISOLATION, SURGICAL
• Manufacturer (Section D): O&M HALYARD, INC.; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 9081563
• MDR Text Key: 158981814
• Report Number: 9081563
• Device Sequence Number: 1
• Product Code: FYC
• UDI-Device Identifier: 10680651696066
• UDI-Public: (01)10680651696066
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 69606
• Device Catalogue Number: 69606-01
• Device Lot Number: LC9125
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1