FDA.reportPublic FDA data

MAUDE MDR 7870261

MDR report key
7870261
Report number
1222993-2018-00018
Event key
0
Event type
3
Date of event
2018-07-31
Date received
2018-09-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
5 CARLISLE ROAD WESTFORD MA 01886 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SCULPSURESCULPSURECYNOSURE INC.PKT100-7026-010105-7026-000N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-1201. O

Event Narratives#

N

Patient 1

IN THIS INCIDENT, PATIENT EXPERIENCED A BLISTER-BURN ON THE ABDOMEN AREA FOLLOWING A LASER PROCEDURE WITH THE SCULPSURE. HOWEVER, IT WAS DETERMINED THAT THE BURN WAS NOT DUE TO THE LASER PROCEDURE, BUT RATHER FROM PATIENT ERROR. THE PATIENT HAD APPLIED AN ICE PACK DIRECTLY ONTO THE LASER TREATED AREA, WHICH RESULTED IN A BLISTER/BURN. AS A RESULT, THE PATIENT DECIDED TO VISIT THE ER FOR CARE. THERE IS NO ADDITIONAL INFORMATION REGARDING THIS FORM OF INTERVENTION. THE CUSTOMER SITE INDICATED THERE WERE NO ADVERSE EFFECTS AS A RESULT OF THE LASER TREATMENT ON THE DAY OF THE PROCEDURE. THEY PROVIDED AN ORAL ANTIBIOTIC FOR PREVENTATIVE CARE. THE TREATMENT PARAMETERS APPLIED IN THE PROCEDURE WERE FOLLOWED PER THE CLINICAL REFERENCE GUIDE. THOUGH THIS PATIENT IMPACT WAS DETERMINED TO BE UNRELATED TO THE EFFECTS OF THE LASER TREATMENT, THIS IS BEING REPORTED BECAUSE THE PATIENT HAD MEDICAL INTERVENTION AT THE EMERGENCY ROOM.

D

Patient 1

PATIENT HAD MEDICAL INTERVENTION FOLLOWING A LASER PROCEDURE.