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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME BIG WHEEL STRETCHER; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO PRIME BIG WHEEL STRETCHER; STRETCHER, WHEELED Back to Search Results
Model Number 1115000000
Device Problem Device Slipped (1584)
Patient Problem Bone Fracture(s) (1870)
Event Date 10/22/2020
Event Type  Injury  
Manufacturer Narrative
Product has not been made available for evaluation.
 
Event Description
It was reported that the mattress slid off of the unit due to missing velcro leading to a patient fall.The patient sustained a broken collar bone as a result.No further details regarding the injury or treatment have been provided.
 
Event Description
It was reported that the mattress slid off of the unit due to missing velcro leading to a patient fall.The patient sustained a broken collar bone as a result.No further details regarding the injury or treatment have been provided.
 
Manufacturer Narrative
The investigation into this event has been completed.The codes in section h have been updated to reflect this.H3 other text : the customer did not make the device available for evaluation.
 
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Brand Name
PRIME BIG WHEEL STRETCHER
Type of Device
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10852861
MDR Text Key216649657
Report Number0001831750-2020-01207
Device Sequence Number1
Product Code FPO
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 01/18/2021
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? Yes
Device Operator No Information
Device Model Number1115000000
Device Catalogue Number1115000000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/22/2020
Initial Date FDA Received11/17/2020
Supplement Dates Manufacturer Received10/22/2020
Supplement Dates FDA Received01/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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