MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 HOOD; GOWN, SURGICAL

Catalog Number	0400800000
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Discarded by the customer.
Event or Problem Description
It was reported that prior to a surgical procedure at the user facility, a foreign material was found on the product.There was no patient involvement, no delay, no medical intervention, and no adverse consequences with this event.

• Brand Name: T4 HOOD
• Common Device Name: GOWN, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7747927
• Report Number: 0001811755-2018-01562
• Device Sequence Number: 13879538
• Product Code: FYA
• UDI-Device Identifier: 34546540152627
• UDI-Public: 34546540152627
• Combination Product (Y/N): N
• PMA/510(K) Number: K070078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2018

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: 0400800000
• Device Lot Number: 17061821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1