MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME BIG WHEEL STRETCHER 30"; STRETCHER, WHEELED

Catalog Number	1115000030
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between july 1-september 30, 2025.This report summarizes 4 malfunction event(s), where it was reported the device experienced accessible sharp edges exposed (metal).No adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.3 device(s) was functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.Evaluation results findings (components/results), 1 device: side rail / fracture problem, 1 device: rod/shaft / no findings available, 1 device: latch / fracture problem, 1 device: holder / fracture problem.There was no remedial action taken.This device is not labeled for single use.
Additional Manufacturer Narrative
This supplemental is being filed to adjust a device code.
Event or Problem Description
No new information.

• Brand Name: PRIME BIG WHEEL STRETCHER 30"
• 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: 23393071
• Report Number: 0001831750-2025-99369
• Device Sequence Number: 10052719
• Product Code: FPO
• UDI-Device Identifier: 07613327278330
• UDI-Public: 7613327278330
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1115000030
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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
• Patient Sex: Unknown