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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 HOOD; GOWN, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO T4 HOOD; GOWN, SURGICAL Back to Search Results
Catalog Number 0400800000
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2017
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure at the user facility, a hair was found on the sterile product.The procedure was completed successfully without a clinically significant delay, adverse consequences, or medical intervention.
 
Event Description
It was reported that during a surgical procedure at the user facility, a hair was found on the sterile product.The procedure was completed successfully without a clinically significant delay, adverse consequences, or medical intervention.
 
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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
casey metzger
4100 east milham avenue
carrigtwohill bus. & tech park
kalamazoo, MI 49001
2693237700
MDR Report Key6642737
MDR Text Key77613029
Report Number0001811755-2017-01315
Device Sequence Number1
Product Code FYA
Combination Product (y/n)N
PMA/PMN Number
K070078
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/23/2017
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
Device Operator Health Professional
Device Catalogue Number0400800000
Device Lot Number16060816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/06/2017
Initial Date FDA Received06/15/2017
Supplement Dates Manufacturer Received08/16/2017
Supplement Dates FDA Received08/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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