MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE SURGICOOL TOGA, 2XL, ZIPPER; GOWN, SURGICAL

Catalog Number 0408841000

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

Discarded at account.

Event Description

It was reported that during a surgical procedure at the user facility, a seam was torn in the toga at both armpit locations.The procedure was completed successfully without any adverse consequences or medical intervention.The surgical delay length was not reported.

Event Description

It was reported that during a surgical procedure at the user facility, a seam was torn in the toga at both armpit locations.The procedure was completed successfully without a clinically significant delay, adverse consequences, or medical intervention.

• Brand Name: FLYTE SURGICOOL TOGA, 2XL, ZIPPER
• 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: 7027366
• MDR Text Key: 92520668
• Report Number: 0001811755-2017-02352
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 7613327117141
• UDI-Public: (01)7613327117141
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0408841000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2017
• 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