FDA Adverse Event Malfunction Summary report: N

MART ANOXOMAT SYSTEM

MDR report key: 2136724 · Received March 27, 2006

Report

Report Number
MW5021048
Event Type
Malfunction
Date Received
March 27, 2006
Date of Event
February 27, 2006
Report Date
March 24, 2006
Manufacturer
MART MICROBIOLOGY BV
Product Code
KZJ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

(B)(6) OF (B)(6) HOSPITAL CENTER CALLED (B)(4) OF (B)(4) TO INDICATE THAT "A LARGE ANOXOMAT JAR EXPLODED, CUT EMPLOYEE'S FACE NEAR EYE, EMPLOYEE WAS TREATED IN THE EMERGENCY ROOM AND RELEASED." THE EMPLOYEE CANNOT RECALL ANY DETAILS OF THE INCIDENT AND THE HOSPITAL WILL NOT RELEASE THE DEVICE TO THE MANUFACTURER, MART MICROBIOLOGY, (B)(4). THE MANUFACTURER CANNOT DETERMINE ANYTHING FURTHER WITHOUT EVALUATING THE DEVICE. (B)(4), A REPRESENTATIVE FROM THE DISTRIBUTOR, (B)(4), VISITED THE HOSPITAL, EXAMINED THE DEVICE AND SPOKE TO THE INJURED EMPLOYEE. THE JAR DID NOT EXPLODE, HOWEVER, A 2 INCH PIECE OF THE LIP ON THE TOP OF THE JAR WAS BROKEN OFF. PICTURES AND A VIDEO ARE AVAILABLE FROM (B)(4). (B)(4) DID NOT OBSERVE ANY INJURIES WHEN SHE SPOKE TO THE INJURED EMPLOYEE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MART ANOXOMAT SYSTEM ANAEROBIC CHAMBER KZJ MART MICROBIOLOGY BV ANX110 NA

Patients

Seq Age Sex Outcome Treatment
1 UNK