FDA.reportPublic FDA data

MAUDE MDR 399292

MDR report key
399292
Report number
MW1025281
Event key
0
Event type
3
Date received
2002-06-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
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
1SILMETDENTAL X-RAY FILMSILMET USAIWZNINININ*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-06-100

Event Narratives#

D

Patient 1

ACCORDING TO RPTR SILMET USA SELLS A DANGEROUS PRODUCT. THE PRODUCT IS THEIR $17.95 BOX OF DENTAL X-RAY FILM FROM CHINA. THIS DENTAL X-RAY FILM HAS THE DIRECTIONAL INDICATOR DOT BACKWARDS FROM ALL OTHER FILM. RPTR HAS SEEN IN THE UNITED STATES SUCH AS THE INDUSTRY STANDARD BY KODAK, FLOW, AND AGFA. THE RESULT OF THIS FILM USE IS BACKWARD FILM PRESENTATIONS. THIS PROBLEM COULD BE MISSED BY THE USER CAUSING THE WRONG PT TOOTH TO BE TREATED. THIS PROBLEM COULD BE MISSED BY ANOTHER DR WHEN FILMS ARE ROUTINELY TRANSMITTED BETWEEN DRS RESULTING IN THE WRONG TOOTH TREATED. RPTR HAS COMPLAINED TO THE CO AS TO THE DANGER OF THIS FILM. TO THEIR KNOWLEDGE THEY ARE STILL SELLING THIS FILM WITH NO CORRECTIONS OR WARNINGS TO THE USER.