FDA.reportPublic FDA data

MAUDE MDR 4781124

MDR report key
4781124
Report number
0001811755-2015-01798
Event key
0
Event type
3
Date of event
2015-04-17
Date received
2015-05-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. CASEY METZGER
Address
4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US
Phone
269-269-2693
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BATTERYINSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENTSTRYKER INSTRUMENTS-KALAMAZOOKIJ4115000000UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-05-190

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE BATTERY WAS OVERHEATING DURING CHARGING AT USER FACILITY. USER SUSTAINED A MINOR BURN TO THUMB AND FOREFINGER WHILE REMOVING THE BATTERY FROM THE CHARGER. THE BURN WAS SUPERFICIAL AND NO MEDICAL INTERVENTION WAS NEEDED.

N

Patient 1

REPORTED EVENT OF OVERHEATING COULD NOT BE CONFIRMED OR DUPLICATED AS THE DEVICE WAS DISCARDED BY THE USER FACILITY. DEVICE IS DISCARDED BY THE USER FACILITY.