MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T5 ZIPPER TOGA W/ PEELAWAY, L/XL; GOWN, SURGICAL

Catalog Number 0400820100

Device Problem Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

Discarded at account.

Event Description

It was reported that prior to a surgical procedure at the user facility, the toga was delaminating and tearing.Tearing could result in a breach in sterile barrier protection between the user and patient.There was no patient involvement, no delay, no medical intervention, and no adverse consequences with this event.

• Brand Name: T5 ZIPPER TOGA W/ PEELAWAY, L/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: 7179993
• MDR Text Key: 96899716
• Report Number: 0001811755-2018-00040
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 4546540502674
• UDI-Public: (01)4546540502674
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0400820100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2017
• 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