OCU-GUARD SUPPLE
Received Jan 22, 1999 · Event occurred Oct 5, 1998
Report 2183620-1999-00002 · MDR key 207370
Device
Generic name
Orbital Implant Wrap
Manufacturer
Bio-vascular, Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Implant extrusion
- Implant, removal of
Patient
12 YR
- Unspecified Infection
- Swelling
- Discharge
- Surgical procedure
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
THE SURGEON REPORTED THAT SHE PERFORMED A FRONTALIS SUSPENSION PROCEDURE USING OCU-GUARD SUPPLE ON 07/31/1998. THE PT EXPERIENCED SWELLING AND DRAINING OF YELLOW MATERIAL FROM INCISION SITE ON 10/05/1998. THIS WAS TREATED BY LANCING AND DRAINING THE INCISION. THE OCU-GUARD SUPPLE BEGAN TO EXTRUDE AND ON 11/02/1998 THE OCU-GUARD SUPPLE WAS EXPLANTED. THE SURGEON REPORTED THE PT ENCOUNTERED A POST-OPERATIVE INFECTION AND IT MAY NOT BE RELATED TO THE USE OF THE OCU-GUARD SUPPLE DEVICE. IT WAS REPORTED THAT NO HARM HAS COME TO THE PT.