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 06/03/2019

Event Type  Injury  

Manufacturer Narrative

The account could not identify which stretcher the nurse was using at the time of the injury.Device not made available for evaluation.

Event Description

It was reported a user was injured when attempting to flip the brake/steer pedal.The injury required the use of crutches.

Manufacturer Narrative

The catalog number and brand name were corrected.

Event Description

It was reported a user was injured when attempting to flip the brake/steer pedal.The injury required the use of crutches.

• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8749884
• MDR Text Key: 149691964
• Report Number: 0001831750-2019-00601
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327278156
• UDI-Public: 07613327278156
• 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,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1115000030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2019
• 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