SILMET NI

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-10 for SILMET NI manufactured by Silmet Usa.

Event Text Entries

[276634] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1025281
• MDR Report Key: 399292
• Date Received: 2002-06-10
• Date Added to Maude: 2002-06-17
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SILMET
• Generic Name: DENTAL X-RAY FILM
• Product Code: IWZ
• Date Received: 2002-06-10
• Model Number: NI
• Catalog Number: NI
• Lot Number: NI
• ID Number: NI
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 388340
• Manufacturer: SILMET USA
• Manufacturer Address: 18968 NE 4TH COURT MIAMI FL 33179 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2002-06-10