MAUDE Adverse Event Report: REBUILDER MEDICAL TECHNOLOGY, INCREBUILDERTHE REBUILDER

Event Date 03/29/2006

Event Type  Injury   Patient Outcome  Other,Required Intervention

Event Description

The product known as "the rebuilder" is only fda approved for pain relief. However, it is being marketed to consumers as "approved for neuropathy. " this is very misleading and the device can get hot or burn if not used properly.

• Brand Name: REBUILDER
• Type of Device: THE REBUILDER
• Manufacturer (Section F): REBUILDER MEDICAL TECHNOLOGY, INC; 636 treeline dr; charlestown WV 25414
• Manufacturer (Section D): REBUILDER MEDICAL TECHNOLOGY, INC; 636 treeline dr; charlestown WV 25414
• Device Event Key: 687098
• MDR Report Key: 698009
• Event Key: 664272
• Report Number: MW1038375
• Device Sequence Number: 1
• Product Code: GZJ
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2006

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/29/2006
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Event Location: Unknown
• Was The Report Sent To Manufacturer?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No
• Is this an Explanted Device?: No Answer Provided