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Adverse Event Report

ELECTRIC MOBILITY CORP. RASCAL 3-WHEELED VEHICLE, MOTORIZED   back to search results
Model Number 245
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Date 08/31/1999
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Customer was traveling up a ramp(18" x 8') and flipped unit. He struck his head on the concrete sidewalk which resulted in fluid on the brain. The customer has had several procedures to relieve this condition.

 
Manufacturer Narrative

The customer has suffered from hydrocephalus as a result of injury. The cause of the incident has not been determined. The suspect unit has been picked up and is enroute back to the manufacturing site for a failure analysis.

 
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Brand NameRASCAL
Type of Device3-WHEELED VEHICLE, MOTORIZED
Baseline Brand NameRASCAL
Baseline Generic NameVEHICLE, MOTORIZED 3-WHEELER
Baseline Catalogue NumberNA
Baseline Model Number245
Other Baseline ID NumberRF070118
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 -0272 ext 2267
Device Event Key239840
MDR Report Key247567
Event Key232195
Report Number2244608-1999-00033
Device Sequence Number1
Product CodeINI
Report Source Manufacturer
Source Type Consumer
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 09/10/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/02/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device MODEL Number245
OTHER Device ID NumberRF090112
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Age1 mo
Event Location Home
Date Report TO Manufacturer09/10/1999
Date Manufacturer Received09/10/1999
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/01/1999
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Unkown

Database last updated on February 28, 2009

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