MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 PULLOVER TOGA, XL; GOWN, SURGICAL

Catalog Number 0400770000

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.

Event Description

It was reported that at the user facility, the plastic on the toga is tearing.No further information about this event has been provided.Attempts are being made to obtain additional information from the user facility.

• Brand Name: T4 PULLOVER TOGA, XL
• Type of Device: GOWN, SURGICAL
• 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: 7169476
• MDR Text Key: 96598603
• Report Number: 0001811755-2018-00019
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 4546540904232
• UDI-Public: (01)4546540904232
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0400770000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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