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

Catalog Number	6390000000
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the user will have to have a partial amputation of a finger.Attempts are being made to gather additional details from the user facility.
Event or Problem Description
It was reported that the user will have to have a partial amputation of a finger.
Additional Manufacturer Narrative
No further information could be gathered regarding the injury and treatment as the event and injury is being handled through legal measures and to stop any future customer contacts.

• Brand Name: POWER LOAD
• 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: 19101275
• Report Number: 0001831750-2024-00360
• Device Sequence Number: 7766360
• Product Code: FPO
• UDI-Device Identifier: 07613327261523
• UDI-Public: 07613327261523
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 6390000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2017
• 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