FDA.reportPublic FDA data

MAUDE MDR 3606090

MDR report key
3606090
Report number
1316463-2014-00001
Event key
0
Event type
3
Date of event
2014-01-03
Date received
2014-01-29
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
PEARLEY BHAMBRI, DIRECTOR
Address
4341 STATE ST. RD. P.O. BOX 220 SKANEATELES FALLS NY 13153 US
Phone
315-315-3156
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
13.5V RECHAREABLE HANDLENAWELCH ALLYN, INC.FCO71000-A71000-AN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-01-290

Event Narratives#

D

Patient 1

THE CUSTOMER ALLEGED THAT THERE WAS AN ELECTRICAL FAILURE INVOLVING A WELCH ALLYN RECHARGABLE HANDLE THAT CAUSED HER ELECTRICAL RECEPTACLE TO CATCH FIRE. THE OTHER OUTLET OF THE RECEPTACLE HAD A WEIGHT SCALE PLUGGED INTO IT. THE ACTUAL CAUSE OF THE FIRE CANNOT BE DETERMINED AT THIS TIME. WE ARE FILLING THIS REPORT IN AN ABUNDANCE OF CAUTION UNTIL FURTHER INVESTIGATION CAN BE CONDUCTED.

N

Patient 1

WELCH ALLYN IS REPORTING THIS EVENT IN AN ABUNDANCE OF CAUTION AS IT IS UNCLEAR WHICH DEVICE OR COMPONENT CAUSED THE PROBLEM. THE DEVICE EVALUATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.