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 Codes	Laceration(s) (1946); Insufficient Information (4580)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the iv pole has a deep scratch leaving a sharp edge which caused a team member and patient to be injured.Further information has not been provided.
Additional Manufacturer Narrative
This unit was unable to be located by the customer for further evaluation.
Event or Problem Description
The user facility confirmed that only one injury occurred.A caregiver sustained a small cut which was treated by a band aid.

• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 23839229
• Report Number: 0001831750-2025-00751
• Device Sequence Number: 18534757
• Product Code: FPO
• UDI-Device Identifier: 07613327278217
• UDI-Public: (01)07613327278217
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 04/30/2026

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?: Yes
• Device Catalogue Number: 1115000000E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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