FDA.reportPublic FDA data

MAUDE MDR 2143474

MDR report key
2143474
Report number
3003900188-2011-00011
Event key
0
Event type
3
Date of event
2011-01-29
Date received
2011-03-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Address
575 MOUNTAIN AVE MURRAY HILL NJ 07974 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGENNONELINDE GAS NORTH AMERICA LLCECX07101604195896* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-03-160

Event Narratives#

D

Patient 1

THIS IS A SPONTANEOUS MEDICAL INCIDENT REPORT FROM A MAINTENANCE ENGINEER AT A HOSP IN BRAZIL CONCERNING A (B)(6) MALE PORTER AT THE HOSP. ON (B)(6) 2011 WHEN THE PORTER TRIED TO OPEN THE COMBILITE TYPE (B)(4) CYLINDER VALVE (GCE COMBILITE I VIPRS, 5 MICRON FILTER, LIV FOR OXYGEN) OF AN OXYGEN CYLINDER USED FOR TRANSPORTATION A FIRE STARTED AND BURNT HIS HAND. THE PORTER HAD 1ST AND 2ND DEGREE BURNS AND WAS ASSISTED IN THE HOSP WHERE HE WORKS AND WAS SENT HOME FOR 5 WORKING DAYS. TREATMENT GIVEN FOR THE BURNS WERE ASEPTIC AND DRESSING WITH SILVER SULFADIAZINE. THEREAFTER HE WAS RECOVERED AND IS BACK TO WORK IN THE SAME ACTIVITIES AS BEFORE THE INCIDENT. ADD'L INFO IS EXPECTED.

N

Patient 1

INVESTIGATION IS ONGOING. EVAL: ACCIDENTAL IGNITION AND FIRE IN OXYGEN VALVE.