MAUDE Adverse Event Report: STRYKER CORPORATION FLYTE SURGICOOL ZIPPERED TOGA; GOWN, SURGICAL

Model Number 0408-831-000

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2019

Event Type  malfunction  

Event Description

When sterile stryker instruments, flyte surgicool toga was opened, a hair was present on the underside of the toga face shield.Fda safety report id# (b)(4).

• Brand Name: FLYTE SURGICOOL ZIPPERED TOGA
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER CORPORATION ; kalamazoo MI 49001
• MDR Report Key: 8831111
• MDR Text Key: 152549013
• Report Number: MW5088392
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: 0408-831-000
• Device Catalogue Number: 0408-831-000
• Device Lot Number: 19030505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR