MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T5 PEEL AWAY HOOD W/ BLUE WRAP; GOWN, SURGICAL

Catalog Number 0400800100S1

Device Problems Torn Material (3024); Material Split, Cut or Torn (4008)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

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

Event Description

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

• Brand Name: T5 PEEL AWAY HOOD W/ BLUE WRAP
• 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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7186580
• MDR Text Key: 97387949
• Report Number: 0001811755-2018-00047
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 4546540502650
• UDI-Public: (01)4546540502650
• 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,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0400800100S1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2018
• 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