FDA.reportPublic FDA data

MAUDE MDR 241662

MDR report key
241662
Report number
1038548-1999-00035
Event key
0
Event type
3
Date of event
1999-08-25
Date received
1999-09-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. PETER STEGAGNO DIRECTOR, QA/RA
Address
5175 S. ROYAL ATLANTA DR TUCKER GA 30084 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EMORY ENDOPLASTIC ELECTROSURGICAL DISSECTORELECTROSURGICAL INSTRUMENTGENZYME SURGICAL PRODUCTSGEI*UNKUNKNYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11999-09-2401. R

Event Narratives#

D

Patient 1

COMPLAINANT STATED THAT DURING AN ENDOSCOPIC BREAST AUGMENTATION PROCEDURE, THE PT RECEIVED A THIRD DEGREE BURN TO AXILLA AS A RESULT OF ARCING BETWEEN THE ELECTROSURGICAL DISSECTOR AND THE RETRACTOR. UPON INSPECTION OF THE DISSECTOR, DAMAGE TO THE INSULATION WAS NOTED. THE COMPLAINANT STATED THAT THE DISSECTOR HAD BEEN INSPECTED PRIOR TO USE AND NO OBVIOUS DAMAGE HAD BEEN NOTED AT THAT TIME. THE TREATMENT GIVEN WAS EXCISION OF THE BURNED AREA AND PRIMARY CLOSURE, AND SCARFADE APPLICATION.