inforMED
InjuryMTZ

OCU-GUARD

Received Oct 8, 2003

Report 2183620-2003-00032 · MDR key 489025

Device

Generic name

Orbital Implant Wrap

Model number

UNK

Catalog number

*

Lot number

UNK

Product problems

  • Melted
  • Device remains implanted

Patient

2 YR

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

IN 2001 (EXACT DATE UNK), PT UNDERWENT ENUCLEATION PROCEDURE FOLLOWED BY IMPLANTATION OF POROUS POLYPROPYLENE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT THREE MONTHS POST-OP PT PRESENTED WITH 16 MM CONJUNCTIVAL MELT OVER OCU-GUARD WRAP; NO INTERVENTION WAS REPORTED. PT POST-OP STATUS: PT RETAINED ORBITAL IMPLANT.