MAUDE MDR 2514308

MDR report key
2514308
Report number
MW5024842
Event key
0
Event type
3
Date of event
2011-12-21
Date received
2012-03-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIFE WAVELIFE WAVE PATCHESBWK N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-03-2801. O

Event Narratives#

D

Patient 1

A FRIEND IS A (B)(4) DISTRIBUTOR AND SINCE I HAVE A DAMAGED TRIGEMINAL NERVE, SHE THOUGHT THE PATCHES HER COMPANY MANUFACTURES COULD HELP REDUCE MY PAIN. I WENT WITH HER TO MEETING WHICH TURNED OUT TO BE A SALES MEETING, MET HER SUPERVISOR (B)(4), AND LEARNED A BIT ABOUT THE PATCHES. I BOUGHT SOME PATCHES AND SHE GAVE ME SOME OF HER OWN TO TRY, BUT I RECEIVED FAULTY INFO ON HOW TO USE THEM. AS A RESULT, WITHIN A COUPLE OF DAYS, THE NERVE PAIN FLARES UP VERY BADLY. I HAD BEEN ON A LOWER DOSE OF MY MEDICATION PRIOR TO THE FLARE AND HAD VERY LITTLE BREAK THROUGH PAIN, BUT AFTER THE IMPROPER USE OF THE PATCHES, THE PAIN WAS CONSTANT AND I HAD TO INCREASE MY DOSAGE ABOUT 70% TO GET THE PAIN UNDER CONTROL. IT IS NOW MONTHS LATER AND I HAVE STILL NOT BEEN ABLE TO GO BACK TO THE PRE-EVENT DOSAGE. I COMPLAINED TO THE COMPANY THAT THEY ARE SENDING DISTRIBUTORS OUT INTO THE FIELDS TO SELL PATCHES TO PEOPLE, BUT THAT THEY DO NOT HAVE ENOUGH TRAINING TO DO IT PROPERLY AND I WAS HURT. THEY NEVER HAD INFORMED CONSENT, THAT THERE COULD BE ADVERSE REACTIONS. I HOPE NO ONE ELSE GETS HURT LIKE I DID. BY THE WAY, THE COMPANY REFUNDED ME FOR MY PURCHASE.