FDA.reportPublic FDA data

MAUDE MDR 2673045

MDR report key
2673045
Report number
1211998-2012-00003
Event key
0
Event type
3
Date of event
2012-07-10
Date received
2012-07-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
109
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
STEVEN BOURDON
Address
411 WAVERLEY OAKS ROAD WALTHAM MA 02452 US
Phone
781-781-7819
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACCU-TEMP CAUTERYACCU-TEMP CAUTERY 1/2 SHAFT W/FINE TIPBEAVER VISITEC INTERNATIONAL, INC.HAMNA844200071674800N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-07-2501. R

Event Narratives#

D

Patient 1

(B)(4). CUSTOMER REPORTED VERBATIM, "DURING SURGERY, A SWAB CAUGHT FIRE AND BURNED THE SURGEON'S THUMB AND THE SIDE OF THE NOSE AND CHEEK OF THE PATIENT." REPEATED ATTEMPTS TO REACH DR. (B)(6) WERE MADE SINCE (B)(6). HE RETURNED OUR CALL ON (B)(6) 2012. OUR CONVERSATION FOUND THAT SURGERY WAS CONDUCTED TO REMOVE A TUMOR ON THE EYE LID. THE SURGEON DECIDED TO DO A CAUTERIZATION OF A SMALL ARTERY NEXT TO THE LACRIMAL GLAND AND CLOSE TO THE CORNEA. TO PROVIDE EASIER ACCESS HE USED A GAUZE (100% COTTON, NON-WOVEN) PLACING IT UNDER HIS LEFT THUMB TO HELP MAKE THE AREA WHERE THE CAUTERIZATION EASIER TO REACH. AS CAUTERIZATION STARTED, HE FELT A SHARP PAIN IN HIS LEFT THUMB AND STARTED SMELLING SOMETHING BURNING. ALMOST IMMEDIATELY THE PATIENT COMPLAINED INDICATING A SHARP PAIN ON THE SIDE OF HER NOSE. DR. (B)(6) IMMEDIATELY STOPPED AND AS HE REMOVED HIS THUMB AWAY FROM THE PATIENT, HE NOTICED THAT THE GAUZE UNDER HIS THUMB HAD DISINTEGRATED LEAVING A RED MARK ON HIS THUMB AND ON THE PATIENT'S NOSE. THE NEXT DAY THE RED MARK ON DR. (B)(6)'S THUMB WAS GONE. HOWEVER, THE PATIENT WAS STILL SHOWING A RED MARK AND CREAM USED TO TREAT SURFACE BURNS WAS APPLIED. THE PATIENT TODAY DOES NOT SHOW ANY MARK. DR. (B)(6) HAS NOT ISSUES WITH HIS THUMB AND HAS BEEN ABLE TO PERFORM SURGERIES WITHOUT ISSUES.

N

Patient 1

PRODUCT HAS BEEN RETURNED, BUT IT APPEARS TO BE A BVI MANUFACTURED UNIT. THIS IS NOT CONSISTENT WITH THE LOT NUMBER REPORTED. THIS PRODUCT LINE WAS RECENTLY ACQUIRED BY MEDTRONIC AND IS NOW MANUFACTURED AT BEAVER VISITEC INTERNATIONAL. HOWEVER, THE REPORTED LOT NUMBER OF THIS PRODUCT SIGNIFIES THAT IT WAS MANUFACTURED BY MEDTRONIC PRIOR TO THIS ACQUISITION. INVESTIGATION IS IN PROGRESS, WHICH INCLUDES INFORMATION FROM MEDTRONIC REGARDING DATE OF MFR, EXPIRATION DATE, AND COMPLAINT TRENDING. EXPECT A FOLLOW-UP REPORT TO BE PROVIDED ON OR ABOUT (B)(4) 2012.