FDA.reportPublic FDA data

MAUDE MDR 2765648

MDR report key
2765648
Report number
MW5027052
Event key
0
Event type
3
Date received
2012-09-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VELASHAPEVELASHAPENUV N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-09-2501. O

Event Narratives#

D

Patient 1

AFTER 1 VELASHAPE TREATMENT, HAD GURGLING WHOOSH IN MY ABDOMEN THAT NIGHT, FELT FINE OTHERWISE. AFTER 2ND VISIT, I BEGAN PUTTING WEIGHT ON IN MY ABDOMEN. THINKING IT WAS JUST A FLUKE CHANGE, I WENT TO MY THIRD VISIT. AGAIN, I PUT ON WEIGHT. CONCERNED, I MET WITH STAFF BEFORE FINAL TREATMENT. WAS TOLD THAT I WAS PROBABLY SLUGGISH IN MY GI TRACT AND IT IS UNRELATED EXCEPT THAT THE TREATMENT WAS PROBABLY ELIMINATING FASTER THAN MY BODY WAS. IT WAS SUGGESTED THAT I GO AHEAD WITH MY 4TH AND FINAL TREATMENT. I DID. I'M BIGGER THAN EVER AND VERY CONCERNED. DATES OF USE: (B)(6) 2012. REASON FOR USE: COULDN'T GET RID OF FAT POUCH AFTER BABIES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.