FDA.reportPublic FDA data

MAUDE MDR 8480358

MDR report key
8480358
Report number
1423537-2019-00301
Event key
0
Event type
3
Date of event
2019-03-13
Date received
2019-04-03
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#

Contact
PATRICIA TUCKER
Address
3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US
Phone
847-847-8478
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SURGICAL CLIPPER, CHARGING BASERAZOR, SURGICALJIANGSU BETTER ELECTRICLWKCAH4414CAH44141424-1377* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-030

Event Narratives#

N

Patient 1

BASED ON THE SUPPLIER INVESTIGATION THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. NO SAMPLE WAS AVAILABLE FOR INVESTIGATION, ONLY A PHOTO WAS PROVIDED. THE SUPPLIER CHECKED THE DEVICE MASTER RECORD AND THERE HAVE BEEN NO CHANGES SINCE PRODUCT LAUNCH. ALL UNITS GO THROUGH 100% IN-PROCESS SYSTEM BURN-IN WITHIN 48 HOURS TO SCREEN OUT WORKMANSHIP PROBLEMS AND PREMATURE DEFECTS AND NO ABNORMALITY WAS FOUND IN THE RECORD. FROM THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. THERE IS NO ACTION TAKEN AT THIS TIME, BUT WE WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

D

Patient 1

A BURNT ODOR WAS COMING FROM SURGICAL CLIPPER CHARGING BASE SO THE CUSTOMER STOPPED USING IT. THERE WAS NO INJURY.