MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER-PRO TL COT; STRETCHER, WHEELED

Catalog Number	6550000000
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Musculoskeletal problem (4535)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
It was originally reported that there were 2 user injuries; however it was confirmed that only one user sustained an injury.
Event or Problem 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: POWER-PRO TL COT
• Common Device Name: 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 Key: 17670477
• Report Number: 0001831750-2023-00990
• Device Sequence Number: 12538902
• Product Code: FPO
• UDI-Device Identifier: 07613327261660
• UDI-Public: 07613327261660
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/01/2024

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 Catalogue Number: 6550000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 08/31/2023; 08/31/2023; 08/31/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 11/22/2023; 12/08/2023; 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown