MAUDE Adverse Event Report: DECHOKER LLC THE 'DECHOKER'

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2016

Event Type  Injury  

Event Description

The 'dechoker', https://www.Dechoker.Com, was used on a girl that was choking in a restaurant that nearly killed her until a physician camer over and performed heimlich maneuver.I later researched the 'dechoker' and found out that they are marking it as a "fda approved" and "fda class ii" device which is very misleading.Https://www.Dechoker.Com http://www.Dechokereurope.Eu (bottom of the page it says fda approved) their tv ads are also very misleading.

• Brand Name: THE 'DECHOKER'
• Type of Device: THE 'DECHOKER'
• Manufacturer (Section D): DECHOKER LLC
• MDR Report Key: 5781700
• MDR Text Key: 49275505
• Report Number: MW5063300
• Device Sequence Number: 1
• Product Code: GCX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2016

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 5 YR
• Patient Weight: 20