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Adverse Event Report

ELECTRIC MOBILITY CORP. RASCAL VEHICLE, 3-WHEEL MOTORIZED   back to search results
Model Number 235
Device Problem Device, incorrect care/use of
Event Date 11/01/1999
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

The customer hit the speed control and ran into the wall fracturing knee cap.

 
Manufacturer Narrative

An authorized service technician evaluated unit. Awaiting formal report which should provide info necessary to complete this form.

 
Search Alerts/Recalls

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Brand NameRASCAL
Type of DeviceVEHICLE, 3-WHEEL MOTORIZED
Baseline Brand NameRASCAL
Baseline Generic NameVEHICLE, MOTORIZED 3-WHEELER
Baseline Catalogue NumberNA
Baseline Model Number235
Other Baseline ID NumberR0164064
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ELECTRIC MOBILITY CORP.
591 mantua blvd
sewell NJ 08080
Manufacturer (Section D)
ELECTRIC MOBILITY CORP.
591 mantua blvd
sewell NJ 08080
Manufacturer Contact
barbara gruman
599 mantua blvd
sewell , NJ 08080
(856) 468 -0270 ext 2267
Device Event Key286237
MDR Report Key295716
Event Key277742
Report Number2246975-2000-00021
Device Sequence Number1
Product CodeINI
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 08/14/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/14/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number235
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Home
Date Report TO Manufacturer08/14/2000
Date Manufacturer Received08/14/2000
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Unkown

Database last updated on January 30, 2009

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