FDA.reportPublic FDA data

MAUDE MDR 7748629

MDR report key
7748629
Report number
3011423170-2018-00075
Event key
0
Event type
3
Date of event
2018-07-09
Date received
2018-08-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. JULI MOORE
Address
3365 TREECOURT INDUSTRIAL BLVD ST LOUIS MO 63122 US
Phone
636-636-6362
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VASERLIPO SYSTEMSYSTEM, SUCTION, LIPOPLASTYSOLTA MEDICAL INCMUU110-0037R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-0301. O

Event Narratives#

N

Patient 1

A LOCAL ENGINEER CHECKED THE SYSTEM AND IT WAS NOT PASSING 10% ON C MODE. IT WAS DETERMINED THE ULTRASOUND BOARD WAS DEFECTIVE. THE DEVICE HAS BEEN REQUESTED FOR FURTHER EVALUATION AND REPAIR, BUT NOT RECEIVED. IT IS LIKELY THAT PATIENT MAY NEED ADDITIONAL THERAPY. A REVIEW OF THE LOT MANUFACTURING RECORDS IS IN PROGRESS.

D

Patient 1

IT WAS REPORTED TO THE DISTRIBUTOR THAT A DOCTOR HAS BEEN USING THE MACHINE SUCCESSFULLY FOR SEVERAL YEARS. THEY WERE PERFORMING A PROCEDURE WITH LOCAL ANESTHESIA ON THE LOWER ABDOMEN OF THE PATIENT. DURING THE TREATMENT THE SYSTEM STOPPED WORKING, THE ULTRASOUND NOISE STOPPED, THERE WAS AN ALARM SOUND AND THE TISSUE WAS RESISTANT TO PROBING DURING THE OPERATION. THIS RESULTED IN UNEVEN LIPOSUCTION, INCREASED PAIN, BLEEDING AND THE SKIN DID NOT TIGHTEN. THE PROCEDURE HAD TO BE COMPLETED USING DIRECT SUCTION BY THE VENTX SYSTEM. THE CONSUMER IS CURRENTLY EXPERIENCING SWELLING OF THE ABDOMEN, AND THERE IS THE POTENTIAL FOR SCARRING. THE CONSUMER WAS TREATED WITH PAIN KILLERS. PICTURES WERE REQUESTED, HOWEVER THE PATIENT REFUSED TO COMPLY.