FDA.reportPublic FDA data

MAUDE MDR 2509202

MDR report key
2509202
Report number
2027969-2012-00415
Event key
0
Event type
3
Date of event
2012-02-28
Date received
2012-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
CARMEN BERGELIN, MANAGER
Address
9975 SUMMERS RIDGE RD SAN DIEGO CA 92121 US
Phone
858-858-8588
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AXIOHM PRINTER, UNIV W/ POWER SUPPLY ONLYALERE SAN DIEGO, INC.CHH14-716NAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-03-270

Event Narratives#

D

Patient 1

CALLER ALLEGED THAT THE PRINTER DATA CABLE WAS HOT AND SOFT AS THOUGH MELTING. PRINTER WAS NOT PRINTING AND THE DATA CABLE WAS HOT TO THE TOUCH. CUSTOMER DESCRIBED IT AS BEING "CURLING IRON HOT" AND THAT THE PLASTIC SHEATH SEEMS SOFT AS THOUGH MELTING. NO ONE WAS BURNED OR INJURED BY THE CABLE. TECHNICAL SERVICES IS REPLACING THE DATA CABLE. CUSTOMER TO RETURN THE FAULTY CABLE.

N

Patient 1

INVESTIGATION PENDING.