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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REBUILDER MEDICAL TECHNOLOGY, INCREBUILDERTHE REBUILDER

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REBUILDER MEDICAL TECHNOLOGY, INC REBUILDER THE REBUILDER   Back to Search Results
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.

 
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Brand NameREBUILDER
Type of DeviceTHE 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 Key687098
MDR Report Key698009
Event Key664272
Report NumberMW1038375
Device Sequence Number1
Product CodeGZJ
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 Received03/29/2006
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

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