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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER LOAD; STRETCHER, WHEELED

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STRYKER MEDICAL-KALAMAZOO POWER LOAD; STRETCHER, WHEELED Back to Search Results
Model Number 6390
Device Problem Device Fell (4014)
Patient Problems Bone Fracture(s) (1870); Hematoma (1884); No Consequences Or Impact To Patient (2199)
Event Date 10/16/2019
Event Type  Injury  
Event Description
It was alleged that a paramedic was injured unloading the power-load.It was reported that the device dropped down and smashed the hand of the paramedic.The user received a contusion and medical attention.
 
Manufacturer Narrative
The user received a hairline fracture and contusion to the finger, further treatment details was not available.Corrected patient code grid.
 
Event Description
It was alleged that a paramedic was injured unloading the power-load.It was reported that the device dropped down and smashed the hand of the paramedic.The user received a hairline fracture and contusion to the finger,.
 
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Brand Name
POWER LOAD
Type of Device
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key9318126
MDR Text Key166323303
Report Number0001831750-2019-01206
Device Sequence Number1
Product Code FPO
UDI-Device Identifier07613327261523
UDI-Public07613327261523
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113598
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number6390
Device Catalogue Number6390000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/17/2019
Initial Date FDA Received11/13/2019
Supplement Dates Manufacturer Received10/17/2019
Supplement Dates FDA Received06/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2019
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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