MalfunctionIWS
PULSE LITE LEAD GLASSES
Received Dec 11, 2006 · Event occurred Dec 11, 2006
Report MW1041329 · MDR key 793011
Device
Generic name
Lead Glasses
Manufacturer
Pulse Medical, IncModel number
PL 100 SCatalog number
*
Lot number
*
Product problems
- Break
Patient
45 YR
- Therapy/non-surgical treatment, additional
- Hospitalization required
Narrative
Description of Event or Problem
MD - RADIOLOGIST- PUT ON SAFETY GLASSES IN MEDICAL IMAGING SPECIAL PROCEDURES ROOM; ATTEMPTED TO ADJUST THEM, WHEN THE RIGHT LENS BROKE AND SLIVER OF GLASS ALLEGEDLY WENT INTO RIGHT EYE. MD WENT TO ED IMMEDIATELY; EYE WAS FLUSHED AND NUMBED, AND MD WAS ORDERED TO SEE AN OPHTHALMOLOGIST.