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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIMEBIG WHEEL ELECT STRETCHER; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO PRIMEBIG WHEEL ELECT STRETCHER; STRETCHER, WHEELED Back to Search Results
Model Number 1115
Device Problem Mechanical Jam (2983)
Patient Problem Bone Fracture(s) (1870)
Event Date 07/22/2021
Event Type  Injury  
Event Description
It is alleged that the caregiver obtained a stress fracture in their foot when utilizing the brake steer pedal.It was reported that the caregiver has been on light duty for weeks following the incident.Further information was not provided.
 
Manufacturer Narrative
The customer did not respond to multiple attempts to provide further information.H3 other text : device not accessible for evaluation.
 
Event Description
It is alleged that the caregiver obtained a stress fracture in their foot when utilizing the brake steer pedal.It was reported that the caregiver has been on light duty for weeks following the incident.Further information was not provided.
 
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Brand Name
PRIMEBIG WHEEL ELECT STRETCHER
Type of Device
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key12355770
MDR Text Key267740456
Report Number0001831750-2021-01305
Device Sequence Number1
Product Code FPO
UDI-Device Identifier07613327278217
UDI-Public07613327278217
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/04/2021
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 Number1115
Device Catalogue Number1115000000E
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/26/2021
Initial Date FDA Received08/23/2021
Supplement Dates Manufacturer Received07/26/2021
Supplement Dates FDA Received11/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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