FDA.reportPublic FDA data

MAUDE MDR 20327

MDR report key
20327
Report number
MW1005464
Event key
0
Event type
3
Date received
1995-03-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DENTAL SYRINGE FILTER DEVICEDENTAL AIR/WATER SYRINGEDCI INTL. CO.EIBN*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11995-03-160

Event Narratives#

D

Patient 1

THIS SYRINGE IS PROMOTED WITH MISLEADING LANGUAGE THAT CLAIMS THAT THIS DEVICE REMOVES "CONTAMINANTS", GIVING THE INCORRECT IMPRESSION THAT IT MAKES A REAL CONTRIBUTION TO INFECTION CONTROL, WHICH IT CERTAINLY DOES NOT. THIS MEDICAL DEVICE IS CLEARLY BEING PRESENTED IN A MISLEADING AND DANGEROUS WAY DESIGNED TO GIVE THE USER A FALSE SENSE OF SECURITY ABOUT WHAT HE IS FILTERING OUT. IT IS POSTURING AS AN INFECTION CONTROL DEVICE BUT SERVES NO USEFUL PURPOSE AS SUCH. (*)