InjuryMTZ
OCU-GUARD
Received Aug 31, 2000 · Event occurred Jul 14, 2000
Report 2183620-2000-00010 · MDR key 294271
Device
Generic name
Orbital Implant Wrap
Manufacturer
Bio-vascular, Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Device remains implanted
Patient
4 YR
- Wound Dehiscence
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
IN 2000, PT RECEIVED AN OCU-GUARD ORBITAL IMPLANT WRAP TO REPAIR A PREVIOUSLY PLACED VICRYL-WRAPPED HYDROXYAPATITE SPHERE, WHICH HAD EXTRUDED AFTER ENUCLEATION. ON 07/14/2000, THE PT PRESENTED WITH CONJUNCTIVAL DEHISCENCE OVER THE OCU-GUARD. PER THE SURGEON'S REPORT, THE DEHISCENCE HAS BEEN ATTRIBUTED TO MODERATE TRAUMA SECONDARY TO TWO PREVIOUS SURGERIES. TO DATE, THE OCU-GUARD HAS NOT BEEN EXPLANTED. THE AREA IS IMPROVING, THE EXPOSED AREA IS REDUCING.