FDA.reportPublic FDA data

MAUDE MDR 8422103

MDR report key
8422103
Report number
1222993-2019-00005
Event key
0
Event type
3
Date of event
2018-05-28
Date received
2019-03-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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.PKT105-7026-000Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-1401. O

Event Narratives#

N

Patient 1

THE PATIENT WAS THEN PROVIDED WITH COLD PACKS, ANTISEPTIC CREAMS, AND LOCAL ANESTHETICS FOR POST TREATMENT CARE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED BY THE INITIAL REPORTER WITH REGARD TO PATIENT DETAILS OR TREATMENT PARAMETERS. THE DEVICE WAS EVALUATED BY A CYNOSURE TECHNICIAN AND FOUND THE UNIT TO BE OPERABLE WORKING WITHIN SPECIFICATION. WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE PATIENT'S INJURY. BURNS ARE EXPECTED SIDE EFFECTS FROM LASER TREATMENT, BUT DUE TO THE SEVERITY OF A 3RD DEGREE BURN, THIS IS A REPORTABLE ADVERSE EVENT.

D

Patient 1

PATIENT HAD A 3RD DEGREE BURN ON THE ABDOMEN-FLANKS AREA FOLLOWING A LASER PROCEDURE.