MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME ZOOM STRETCHER30INLITTER; STRETCHER, WHEELED POWERED

Catalog Number 1125000030

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Date 09/29/2015

Event Type  Injury  

Manufacturer Narrative

A visual and functional inspection was performed by the field service representative who identified that the stretcher had no defect.

Event Description

It was reported that the user of the stretcher was pulling the stretcher behind them over a bump on a descending ramp, when the stretcher accelerated more than the user had anticipated.As a result, the shroud of the base ran over their heel as they stuck their leg out in an attempt to stop the stretcher movement with their hip.It was reported that the user received a laceration that required 3 stitches and prescribed medication.

• Brand Name: PRIME ZOOM STRETCHER30INLITTER
• Type of Device: STRETCHER, WHEELED POWERED
• 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: 5181639
• MDR Text Key: 29415327
• Report Number: 0001831750-2015-00535
• Device Sequence Number: 1
• Product Code: INK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 1125000030
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2015
• 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