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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 POWER PACK; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO T4 POWER PACK; HELMET, SURGICAL Back to Search Results
Catalog Number 0400650000
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 04/29/2015
Event Type  malfunction  
Event Description
It was reported that during testing conducted at the manufacturer facility the device was leaking an unknown substance.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
Failure analysis is in progress.
 
Event Description
It was reported that during testing conducted at the manufacturer facility, the device was leaking an unknown substance.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device was scrapped by stryker.
 
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Brand Name
T4 POWER PACK
Type of Device
HELMET, 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
kalamazoo, MI 49001
2693237700
MDR Report Key4771759
MDR Text Key17628465
Report Number0001811755-2015-01753
Device Sequence Number1
Product Code FXZ
Combination Product (y/n)N
Reporter Country CodeUS
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 04/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0400650000
Device Lot Number15021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received06/24/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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