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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AUTOMATIC HIGH VACUUM FOOT PUMP; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-KALAMAZOO AUTOMATIC HIGH VACUUM FOOT PUMP; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0206500000
Device Problem Material Fragmentation (1261)
Patient Problems Hearing Loss (1882); No Consequences Or Impact To Patient (2199)
Event Date 01/03/2019
Event Type  malfunction  
Event Description
It was reported that the metal valve on the end of the device popped off.There was no associated procedure as the event occurred during testing.However, it was further reported at the time that a nurse was being evaluated for a potential hearing injury.Additional information has been requested from the user facility.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that the metal valve on the end of the device popped off.There was no associated procedure as the event occurred during testing.It was initially reported that a nurse standing next to the tank needed to be evaluated for potential hearing injuries but it was later confirmed that no follow up care was needed and there were no adverse consequences to report.
 
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Brand Name
AUTOMATIC HIGH VACUUM FOOT PUMP
Type of Device
MIXER, CEMENT, FOR CLINICAL USE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8293133
MDR Text Key134606597
Report Number0001811755-2019-00452
Device Sequence Number1
Product Code JDZ
UDI-Device Identifier04546540039378
UDI-Public04546540039378
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0206500000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2019
Date Manufacturer Received01/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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