OtherHMP
JOHNSON & JOHNSON EYE PADS
Received Aug 22, 1997 · Event occurred Jul 1, 1997
Report 1618732-1997-00182 · MDR key 114732
Device
Generic name
Pads, Eye
Manufacturer
Johnson & Johnson Medical, Inc.Model number
NACatalog number
8771
Lot number
AUG;53161
Product problems
- Unknown (for use when the device problem is not known)
Patient
28 YR
- Inflammation
- Itching Sensation
- Scar Tissue
Narrative
Description of Event or Problem
CALLER STATES THAT PC8771 WAS USED TO COVER THE EYE OF A 28 YEAR OLD FEMALE. SIX HOURS LATER SHE COMPLAINED OF A RAISED RED ITCHING REACTION. PT DID NOT RETURN TO THE DR FOR A FOLLOWUP UNTIL 8/18/97. THE DR HAS FOUND "SUPERFICIAL SCARRING UNDER HER EYE." THE CURRENT PT CONDITION WAS CALLED IN ON 8/19/97.