FDA Adverse Event Injury Summary report: N

CHARITE DISC

MDR report key: 1570799 · Received December 26, 2009

Report

Report Number
MW5014178
Event Type
Injury
Date Received
December 26, 2009
Date of Event
September 12, 2005
Report Date
December 26, 2009
Manufacturer
JOHNSON & JOHNSON
Product Code
MJO
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

I MUST TELL THAT THIS CHARITE DISC I GOT HAS DESTROYED MY YOUNG HEALTHY LIFE. ALL I WANTED / NEEDED WAS FUSION. BUT MY DOCTOR SAID THOSE JUST FAIL AND MADE ME WAIT FOR NEW TECHNOLOGY. HAD A TERRIBLE TIME RECOVERING, LOST 50% OF BLADDER FUNCTION, MUST CATHETERIZE MYSELF. HAVE TERRIBLE PAIN LEVEL 7/8 NEARLY ALWAYS. GROIN PAIN, ABDOMINAL PAIN, LOSS OF MUSCLE TONE, DIGESTION IS A MESS, CONTINUED LEG PAIN BURNING, AND I'M DISABLED. DOCTOR WANTED TO REMOVE DEVICE AFTER FIVE MONTHS, BUT SAID IT MAY KILL ME. MAY HAVE TO LEAVE IT AND BACK OUT. NOW ON DISABILITY/ WAS A HARD WORKING MAN FOR MANY YEARS. BECAUSE, I WAS SOLD A MEDICAL DEVICE I DIDN'T NEED. I AM A VICTIM. DOCTORS HAVE SAID THIS DISC NEEDS TO COME OUT OR SOME SORT OF STABILIZATION, BUT NO DOCTOR WILL HELP ME. HAVE BEEN TO FOUR AND THEY ALL SAY THEY CAN'T HELP ME OR WON'T SEE ME. BECAUSE I HAVE A CHARITE DISC. I'M IN TERRIBLE PAIN ALL THE TIME, ON SEVEN MEDS. IN ADDITION, I'M TOLD THERE IS NO LEGAL RECOURSE FOR WHAT HAS BEEN DONE TO ME, BECAUSE THE "FDA APPROVED THE DEVICE". THEREFORE, I'M UNABLE TO SEEK DAMAGES BECAUSE OF PREEMPTION THEY SAY. I AM CONVINCED IF I HAD GOTTEN FUSION, I WOULD BE WORKING TODAY. HAVE TWO RUPTURED LEVELS L4 AND L5, DOCTOR PUT CHARITE DISC ON L5 WHAT ABOUT L4? HE EXPERIMENTED ON ME, I KNOW IT. NO DOCTOR WILL HELP ME. I'M IN BAD SHAPE. HAVE NO MONEY ANYWAY TO PAY DOCTOR. NEEDS TO HELP ME, FIX THIS, I DON'T KNOW WHAT TO DO, PLEASE HELP. DON'T WANT TO DIE YET. I DON'T KNOW WHAT ELSE TO DO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CHARITE DISC ARTIFICIAL DISC MJO JOHNSON & JOHNSON

Patients

Seq Age Sex Outcome Treatment
1 42 YR Required Intervention