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

Catalog Number 0400800000

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

Device not returned.

Event Description

It was reported that prior to a surgical procedure at the user facility, foreign material was found in the sterile packaging of the product.There was no patient involvement, no delay, no medical intervention and, no adverse consequences with this event.

• Brand Name: T4 HOOD
• 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: 7778930
• MDR Text Key: 117005238
• Report Number: 0001811755-2018-01578
• Device Sequence Number: 1
• Product Code: FYA
• UDI-Device Identifier: 34546540152627
• UDI-Public: 34546540152627
• Combination Product (y/n): N
• 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
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0400800000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2018
• 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