FDA.reportPublic FDA data

MAUDE MDR 490848

MDR report key
490848
Report number
490848
Event key
0
Event type
3
Date of event
2003-02-01
Date received
2003-10-23
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
1*TONSIL SYRINGEUNKKBZ***N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-10-2301. O

Event Narratives#

D

Patient 1

A GLASS TONSIL SYRINGE BROKE WHILE INJECTING BUT APPEARED INTACT. A GLASS PIECE WAS RETRIEVED FROM THE SURGICAL DRAPE BUT NONE WAS FOUND ON THE PT.