FDA.reportPublic FDA data

MAUDE MDR 8500051

MDR report key
8500051
Report number
MW5085721
Event key
0
Event type
3
Date of event
2019-04-01
Date received
2019-04-09
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
1CAVITATION RF SLIMMING SYSTEM ZIRRA BY ZEMITSMASSAGER, THERAPEUTIC, ELECTRICADVANCE - ESTHETIC LLCISAHTTP://ADVANCE-ESTHETIC.US/CAVI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-0901. O

Event Narratives#

D

Patient 1

HAD A TREATMENT WITH THE RF CAVITATION TENS POWERED STIMULATORS MACHINES AND WAS BURNED. ALL THESE MACHINES REQUIRE FDA 510K CLEARANCE AND THEY IMPORT FROM (B)(4) AND DO NOT HAVE ANY FDA 510K APPROVALS. PLEASE SHUT THIS COMPANY DOWN: ESTABLISHMENT: (B)(6), (B)(4), STATUS: ACTIVE, DATE OF REGISTRATION STATUS: 2019; OWNER/OPERATOR: (B)(6), OWNER/OPERATOR NUMBER: (B)(4), OFFICIAL CORRESPONDENT: (B)(6), PHONE: (B)(6). (B)(6). FDA SAFETY REPORT ID# (B)(4).