X-RAY FILM MARKING TAPE 314X - 175 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-17 for X-RAY FILM MARKING TAPE 314X - 175 * manufactured by Spectronics, Corp..

Event Text Entries

[18949564] Labels are used to mark industrial radiographic film used when performing x-ray inspections on aircraft. The labels must have all identifying info embossed, normally with a ball-point pen, in the grey putty center of the tape. Upon exposure to x-rays, thin areas where writing has been made leave an image of all identifying info on the xray film. In this case, the putty in the label has become so decomposed that it has turned from a gray putty to an off-white powder. Rptr's experience is that this condition normally occurs due to either time since mfr or improper storage and renders the label unserviceable. Very old product. Mfr date 6/82, 12/82.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW4001921
MDR Report Key	98688
Date Received	1997-06-17
Date of Report	1996-09-30
Date Added to Maude	1997-06-19
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
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	X-RAY FILM MARKING TAPE
Generic Name	X-RAY FILM MARKING TAPE
Product Code	JAC
Date Received	1997-06-17
Model Number	314X - 175
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	*
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	97270
Manufacturer	SPECTRONICS, CORP.
Manufacturer Address	956 BRUSH HOLLOW RD WESTBURY NY 11590 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-06-17