MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-04-01 for PREFORMED OCU-GUARD SUPPLE UNK manufactured by Bio-vascular, Inc..
[137316]
Prior to the event described, the pt was implanted on 11/19/98 with a hydroxyapatite ocular implant wrapped in ocu-guard. This was to treat the pt for anophthalmos, no eye, due to an enucleation without implant which had been performed 36 years prior. No concomitant surgical procedure was performed on this pt during the time of this implant surgery. Within one week of the implant surgery, the pt presented with significant orbital inflammation, swelling and edema. The pt was treated with steroids on 11/25/98 for this complication. The pt is reported as stable and did not suffer any harm due to this complication. The surgeon has reported that the use of ocu-guard, the orbital implant wrap, can not be directly attributed to this complication. The surgeon reported no new techniques or procedures from the over 100 enucleation surgeries he has used using the hydroxyapatite ocular implants wrapped in ocu-guard.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183620-1999-00011 |
| MDR Report Key | 217251 |
| Report Source | 05 |
| Date Received | 1999-04-01 |
| Date of Report | 1999-04-01 |
| Date of Event | 1998-11-19 |
| Date Mfgr Received | 1999-03-29 |
| Device Manufacturer Date | 1998-02-01 |
| Date Added to Maude | 1999-04-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREFORMED OCU-GUARD SUPPLE |
| Generic Name | ORBITAL IMPLANT WRAP |
| Product Code | MTZ |
| Date Received | 1999-04-01 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | OGSP-98B17 |
| ID Number | NA |
| Device Expiration Date | 2003-02-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 210730 |
| Manufacturer | BIO-VASCULAR, INC. |
| Manufacturer Address | 2575 UNIVERSITY AVE. ST. PAUL MN 551141024 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-04-01 |