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

Catalog Number	0400750000
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product discarded.
Event or Problem Description
It was reported that during a surgical procedure at the user facility, the toga material seemed thinner and tore.The procedure was completed successfully without a clinically significant delay, adverse consequences, or medical intervention.

• Brand Name: T4 PULLOVER TOGA, REGULAR
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7931388
• Report Number: 0001811755-2018-01716
• Device Sequence Number: 13918136
• Product Code: FYA
• UDI-Device Identifier: 34546540904189
• UDI-Public: 34546540904189
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K070078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/03/2018

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: 0400750000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1