MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME BIG WHEEL STRETCHER 26IN; STRETCHER, WHEELED

Catalog Number 1115000026

Device Problem Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.2 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 2 malfunction events, where it was reported the devices experienced accessible sharp metal edges.There was no patient involvement.

Manufacturer Narrative

After further investigation, it was found that the devices had sharp plastic edges, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 2 to 0.

Event Description

This report summarizes 0 malfunction events, where it was reported the devices experienced accessible sharp metal edges.There was no patient involvement.

• Brand Name: PRIME BIG WHEEL STRETCHER 26IN
• Type of Device: 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18004936
• MDR Text Key: 326605807
• Report Number: 0001831750-2023-01275
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327278231
• UDI-Public: 07613327278231
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1115000026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1