MalfunctionHNM
5192 FRONTALIS SUSPENSION SET
Received May 6, 1998 · Event occurred Mar 18, 1998
Report 1047439-1998-00001 · MDR key 167216
Patient
50 YR
Narrative
Description of Event or Problem
PERFORMED BILATERAL FRONTALIS SLINGS USING PRODUCT 5192 ON 10-23-97. MADE ADJUSTMENT TO RIGHT EYE ON 2-13-98. ON 3-18-98, DRAMATIC PTOSIS WAS NOTED ON RIGHT EYE. WOUND WAS OPENED AND IT WAS FOUND THAT THE SLING HAD BROKEN.
Remedial action
- Replace