MAUDE MDR 6893796

MDR report key
6893796
Report number
MW5072418
Event key
0
Event type
3
Date of event
2017-07-15
Date received
2017-09-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FASCIABLASTERCOMPONENTS, EXERCISEASHLEY BLACK/ADB INTERESTS, LLCIODI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-2501. O

Event Narratives#

D

Patient 1

DATE IS APPROXIMATE. AFTER USING A DEVICE CALLED THE FASCIA BLASTER FOR SEVERAL MONTHS. I BEGAN TO EXPERIENCE INTENSE AND IMMOBILIZING PERIOD CRAMPS. I HAVE USED THE TOOL, AS INSTRUCTED, ON MY ABDOMEN. ONCE I REALIZED THE POTENTIAL CONNECTION, I STOPPED USING IT. I WENT TO THE DOCTOR AND MAY NEED SURGERY DUE TO A PROLAPSE. WHILE A PROLAPSED UTERUS IS VERY COMMON IN WOMEN WHO HAVE HAD CHILDREN, THE SUDDEN ONSET AS WELL AS THE SEVERITY OF THE SYMPTOMS MADE ME CONNECT IT TO MY USE OF THIS DEVICE. I WAS PLANNING TO GET SURGERY, AS INSTRUCTED, BUT, WITHOUT INTERVENTION, IT SEEMS TO BE IMPROVING WHICH IS NOT THE USUAL COURSE. I HAD HORRIFIC BRUISING FROM THE DEVICE AND WAS TOLD THAT WAS "GOOD" AND SUPPOSED TO HAPPEN. I SIGNIFICANTLY DAMAGED MY BODY IN OTHER WAYS AS WELL. WHEN I DESCRIBED WHAT HAPPENED TO ME IN AN OPEN FORUM, QUITE A FEW PEOPLE CAME FORWARD WITH SIMILAR STORIES SOME OF WHO HAD NOT CONNECTED IT TO THE USE OF FASCIABLASTER. THIS IS A HORRIBLY DANGEROUS PRODUCT AND NEEDS TO BE INVESTIGATED.