RASCAL 230 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1999-05-07 for RASCAL 230 NA manufactured by Electric Mobility Corp.

Event Text Entries

[131034] The customer stated he was riding his unit in the hosp. The speed of the unit was set between 3 & 4. As he turned a corner, the unit reared up and he fell out of the unit. A hosp employee tried the unit and the same condition occurred. The customer was treated and released.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2244608-1999-00007
• MDR Report Key: 222850
• Report Source: 04
• Date Received: 1999-05-07
• Date of Report: 1999-04-01
• Date of Event: 1999-04-01
• Date Reported to Mfgr: 1999-04-01
• Date Mfgr Received: 1999-04-01
• Device Manufacturer Date: 1997-07-01
• Date Added to Maude: 1999-05-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RASCAL
• Generic Name: VEHILCE, MOTORIZED 3-WHEELER
• Product Code: INT
• Date Received: 1999-05-07
• Model Number: 230
• Catalog Number: NA
• Lot Number: NA
• ID Number: RF062092
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Age: 1.5 YR
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 216110
• Manufacturer: ELECTRIC MOBILITY CORP
• Manufacturer Address: 599 MANTUA BLVD SEWELL NJ 08080 US
• Baseline Brand Name: RASCAL
• Baseline Generic Name: VEHILCE, MOTORIZED 3-WHEELER
• Baseline Model No: 230
• Baseline Catalog No: NA
• Baseline ID: RF062092

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-05-07