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

Catalog Number	1115000000E
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.5 device(s) was/were functionally/visually inspected in the field.The device(s) was/were repaired and returned to use.Evaluation results findings (components/results).1 device: side rail / fracture problem.1 device: pusher / fracture problem.2 devices: latch / fracture problem.1 device: rod/shaft / material and/or chemical problem identified.3 devices are pending evaluation.Evaluation results findings (components/results).3 devices: insufficient information / results pending completion of investigation.There was no remedial action taken.This device is not labeled for single use.
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 october 1 - december 31, 2025.This report summarizes 8 malfunction event(s), where it was reported the device experienced accessible sharp metal edges.No adverse consequence or clinically relevant delay in treatment was reported.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
This supplemental is being filed to include an additional results code following the completion of a device investigation.
Additional Manufacturer Narrative
1 device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Evaluation results findings (components/results).1 device: rod/shaft/material and/or chemical problem identified.2 devices that were pending were evaluated and it was determined the devices experienced cosmetic/aesthetics issue, not affecting function and sharp plastic edge, which is not reportable.
Event or Problem Description
This report now summarizes 6 malfunction event(s), instead of 8.

• Brand Name: PRIME ELECTRIC BIG WHEEL STRETCHER
• 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: 24181414
• Report Number: 0001831750-2026-99052
• Device Sequence Number: 15824232
• Product Code: FPO
• UDI-Device Identifier: 07613327278217
• UDI-Public: 7613327278217
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 6
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2026

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: 1115000000E
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/01/2026
• Supplement Date Received by Manufacturer: 01/01/2026; 01/01/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/20/2026; 04/01/2026
• 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
• Patient Sex: Unknown