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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DECHOKER LLC THE 'DECHOKER'

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DECHOKER LLC THE 'DECHOKER' Back to Search Results
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.

 
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Brand NameTHE 'DECHOKER'
Type of DeviceTHE 'DECHOKER'
Manufacturer (Section D)
DECHOKER LLC
MDR Report Key5781700
MDR Text Key49275505
Report NumberMW5063300
Device Sequence Number1
Product Code GCX
Combination Product (Y/N)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2016
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
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/06/2016 Patient Sequence Number: 1
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