FDA.reportPublic FDA data

MAUDE MDR 4804313

MDR report key
4804313
Report number
4804313
Event key
0
Event type
3
Date of event
2015-04-07
Date received
2015-04-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STORZLACRIMAL DUCT DILATORBAUSCH AND LOMBHNW*** Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-04-140

Event Narratives#

D

Patient 1

DURING LACRIMAL DUCT DILATION AND PROBING WITH POSSIBLE STENT PLACEMENT, THE PHYSICIANS NOTED SMALL METAL FRAGMENTS ON THE INSIDE OF THE EYE AS WELL AS IN THE LACRIMAL DUCT. IT WAS FOUND TO BE COMING OFF OF ONE OF THE LACRIMAL DILATORS. THE PHYSICIANS WERE ABLE TO REMOVE FRAGMENTS FROM THE EYE AND LACRIMAL DUCT SO THE PATIENT DID NOT SUSTAIN ANY INJURY.