MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; STRETCHER, WHEELED

Catalog Number UNK_MED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was alleged that the user facility has had a few employee injuries with the stretchers ordered last year for the emergency department.Further information on the type and extent of the injures and how they are related to the stretchers was not reported.

Manufacturer Narrative

It was reported that an employee¿s foot was injured¿ while using the stretcher.It was reported that the employee's needed to take time off work.No further information was available on the extent of the injury.The user facility also confirmed that the injury occurred as the combined result of the employee needing training on how to use the unit and the steer mechanism being difficult to engage/disengage.The steer mechanism being difficult to engage/disengage could not be confirmed as the device was not accessible for evaluation.

Event Description

It was alleged that the user facility has had an employee injury with the stretcher ordered last year for the emergency department.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18808152
• MDR Text Key: 336568150
• Report Number: 0001831750-2024-00320
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other