FDA.reportPublic FDA data

MAUDE MDR 2334876

MDR report key
2334876
Report number
MW5023029
Event key
0
Event type
3
Date of event
2011-08-10
Date received
2011-11-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CMFSTIMULATORDJO GLOBALLOE

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-0701. H; 2. L; 3. R

Event Narratives#

D

Patient 1

NECK SURGERY (B)(4) 2011. PRESCRIBED A GROWTH STIMULATOR LATE (B)(4) 2011. LATE (B)(4) THE LYMPH NODES IN MY NECK SWELLED UP WHERE THE NECK SURGERY WAS DONE AND THE SURGEON REFERRED ME TO MY TO PRIMARY CARE. IN TURN I WAS REFERRED TO A SPECIALIST WHO DIAGNOSED LYMPHOMA IN MY NECK, (B)(4) 2011. DATES OF USE: (B)(4) 2011. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.