FDA.reportPublic FDA data

MAUDE MDR 7673391

MDR report key
7673391
Report number
MW5078295
Event key
0
Event type
3
Date of event
2018-05-16
Date received
2018-07-09
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
1MEDOVATIONS INNERVISION DETACHABLE BOUGIE TIPS 50FRETRACTOR, FIBEROPTICMEDOVATIONS INC. / DIVERSATEK HEALTHCARE INC.FDG1465-50221575I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-0901. R

Event Narratives#

D

Patient 1

A 50F BOUGIE TIP BECAME DISLODGED FROM THE ILLUMINATION CORD IN THE PT'S ESOPHAGUS.