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

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 06/11/2020

Event Type  malfunction  

Event Description

Rn opened clean yellow isolation gown, one sleeve went in as normal, second armhole opening was sewn completely shut.There was however an opening on the other side of gown, rendering the gown not usable.

• Brand Name: HALYARD ISOLATION GOWNS
• Type of Device: GOWN, ISOLATION
• Manufacturer (Section D): O&M HALYARD, INC; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 10257152
• MDR Text Key: 198317643
• Report Number: 10257152
• Device Sequence Number: 1
• Product Code: FYC
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1