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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER-PRO TL COT; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO POWER-PRO TL COT; STRETCHER, WHEELED Back to Search Results
Catalog Number 6550000000
Device Problems Difficult or Delayed Positioning (1157); Patient Device Interaction Problem (4001)
Patient Problems Bone Fracture(s) (1870); Unspecified Musculoskeletal problem (4535)
Event Date 08/03/2023
Event Type  Injury  
Event Description
It was reported that a user began pulling the device when the push handle snapped.Both users sustained musculoskeletal injuries causing a period of absence from work.There were no adverse consequences to the patient.Attempts are being made to gather additional injury and treatment details as well as the serial number from the user facility.
 
Manufacturer Narrative
It was originally reported that there were 2 user injuries; however it was confirmed that only one user sustained an injury.
 
Event Description
It was reported that a user began pulling the device when the push handle snapped.One user sustained musculoskeletal injury causing a period of absence from work.There were no adverse consequences to the patient.Attempts are being made to gather treatment details as well as the serial number from the user facility.
 
Event Description
It was reported that a user began pulling the device when the push handle snapped.One user sustained a left elbow fracture.An x-ray was completed and was undergoing physical therapy.There were no adverse consequences to the patient.
 
Manufacturer Narrative
The push handle that snapped off was returned to the stryker facility and it was confirmed that the corner handle assembly was broken.The serial number was unable to be obtained.
 
Event Description
It was reported that a user began pulling the device when the push handle snapped.One user sustained a left elbow fracture.An x-ray was completed and was undergoing physical therapy.There were no adverse consequences to the patient.
 
Manufacturer Narrative
Corrected the device code.
 
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Brand Name
POWER-PRO TL COT
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
melissa simon
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key17670477
MDR Text Key322501854
Report Number0001831750-2023-00990
Device Sequence Number1
Product Code FPO
UDI-Device Identifier07613327261660
UDI-Public07613327261660
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 02/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Catalogue Number6550000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/31/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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