MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 ZPR TOGA W/INT SHLDR TIES; SURGICAL, GOWN

Catalog Number 0400820001

Device Problems Delamination (2904); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Discarded at account.

Event Description

It was reported that at the user facility, there was a tear in the toga and the outer layer of plastic was peeling off.The procedure was completed successfully without a clinically significant delay, adverse consequences, or medical intervention.

• Brand Name: T4 ZPR TOGA W/INT SHLDR TIES
• Type of Device: SURGICAL, GOWN
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7299608
• MDR Text Key: 101168714
• Report Number: 0001811755-2018-00461
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0400820001
• Device Lot Number: 17082217
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1