MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME BIG WHEEL STRETCHER30IN; STRETCHER, WHEELED

Catalog Number 1115000030

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

Patient Problem Injury (2348)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

Upon completion of the device evaluation by a field service representative, it was found that the device had no defect and the alleged complaint could not be recreated or duplicated.No parts were replaced and the unit was returned to service.

Event Description

It was reported that the user received a foot injury while engaging the brakes.Further information was not provided.

• Brand Name: PRIME BIG WHEEL STRETCHER30IN
• 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: 8592851
• MDR Text Key: 144528962
• Report Number: 0001831750-2019-00562
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327278330
• UDI-Public: 07613327278330
• 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: 05/08/2019

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?: No
• Device Operator: No Information
• Device Catalogue Number: 1115000030
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2012
• 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