FDA.reportPublic FDA data

MAUDE MDR 8042236

MDR report key
8042236
Report number
MW5081074
Event key
0
Event type
3
Date of event
2018-10-22
Date received
2018-11-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0FLEXIMA ALL PURPOSE DRNG LOOP CATHETERTUBE, DRAINAGE, SUPRAPUBICBOSTON SCIENTIFIC CORPORATIONFFAM00127138021091453I Y
1FLEXIMA ALL PURPOSE DRNG LOOP CATHETERCHEST TUBE/CATHETER, NEPHROSTOMY, GENERAL AND PLASTIC SURGERYBOSTON SCIENTIFIC CORPORATIONGBOM00127138021091453I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-0501. R

Event Narratives#

D

Patient 0

TUBE SEPARATED NEAR VALVE IN AN AREA UNCOMMON FOR TUBE/CATHETER TO SEPARATE.