MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BIG WHEEL STRETCHER, PRIME X; Stretcher, Wheeled

Catalog Number	1115000000X
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while transporting a product, the office worker's finger got caught under the bed when they went over a step resulting in a fractured finger.The customer reported that, although an adverse event occurred, the product was functioning correctly, and the customer did not wish to have the device inspected.

• Brand Name: BIG WHEEL STRETCHER, PRIME X
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; +1(269)329-2100
• MDR Report Key: 25209439
• Report Number: 0001831750-2026-00040
• Device Sequence Number: 13380209
• Product Code: FPO
• UDI-Device Identifier: 07613327278248
• UDI-Public: 07613327278248
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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 Catalogue Number: 1115000000X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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