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

Catalog Number	0408830100
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure at the user facility, the toga ripped.The procedure was completed successfully without a clinically significant delay, adverse consequences, or medical intervention.

• Brand Name: FLYTE TOGA, XL, ZIPPER, PEELAWAY
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7759513
• Report Number: 0001811755-2018-01570
• Device Sequence Number: 16463748
• Product Code: FYA
• UDI-Device Identifier: 34546540591822
• UDI-Public: 34546540591822
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K073017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0408830100
• Device Lot Number: 1801053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1