FDA Adverse Event Injury Summary report: N

REBUILDER 3000

MDR report key: 1125964 · Received August 16, 2008

Report

Report Number
MW5008018
Event Type
Injury
Date Received
August 16, 2008
Date of Event
May 27, 2008
Report Date
August 16, 2008
Manufacturer
REBUILDER MEDICAL INC.
Product Code
GZJ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

AFTER USING THE REBUILDER MEDICAL DEVICE WITH THE TWIN COMPARTMENT PLASTIC FOOTBATH, ELECTROSALT AND ELECTRODE PADS IN THE BATH NEXT TO MY FEET ON THE 2.5 SETTING ON THE REBUILDER DEVICE FOR ALMOST 30 DAYS, I STARTED GETTING LEG SPASMS AND CRAMPS IN BOTH LOWER LEG MUSCLES, SO I CALLED THE REBUILDER NUMBER, TO GET AN AUTHORIZATION NUMBER TO RETURN THE REBUILDER AND PARTS AND GET A REFUND. THE FEMALE REP WHO SPOKE TO ME WAS SURPRISED THAT I HAD LEG PROBLEMS ON THE 2.5 SETTING, BUT CONVINCED ME TO TRY THE REBUILDER FOOTBATH ON LOWER SETTINGS BEFORE I RETURNED IT. SO, I DID, I CONTINUED TO HAVE THE CRAMPS AND LEG SPASMS IN 2008, EVEN THOUGH, I TRIED THE LOWEST SETTING AND GAVE MY LEGS AND FEET A REST FOR A FEW DAYS BETWEEN USES OF THE FOOTBATH AND DEVICE, AS THE DIRECTIONS STATED. ON THE FOLLOWING MONTH, I AGAIN CALLED AND EXPLAINED TO THE MAN WHO TAKES RETURNS THAT I HAD ONLY KEPT THE REBUILDER, BECAUSE HIS REP TOLD ME TO TRY LOWER NUMBERS ON THE REBUILDER DEVICE, AND GIVE MORE TIME BETWEEN USES TO SEE IF THAT WOULD HELP. HE SAID THAT I HAD GONE OVER THE PERIOD FOR A FULL REFUND WITH A RETURN. I ASKED HIM ABOUT A PARTIAL REFUND, AND HE SAID HE COULD NOT REFUND. I BOUGHT THIS DEVICE BASED ON THE FDA APPROVAL AND NEUROPATHY ASSOC APPROVAL. HOWEVER, I STILL HAVE NUMBNESS IN MY FEET AND BURNING AND INFREQUENT PAIN. I DO HAVE THE LEG SPASMS OR CRAMPS, SINCE I STOPPED USING THE REBUILDER. I AM DIABETIC.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 REBUILDER 3000 REBUILDER GZJ REBUILDER MEDICAL INC. REBUILDER 3000

Patients

Seq Age Sex Outcome Treatment
1 65 YR Other