MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2011-09-23 for COATED BIO-EYE HA IMPLANT I0020C manufactured by Integrated Orbital Implants.
[48116973]
Exposures are an anticipated complication from orbital implant surgery.
Patient Sequence No: 1, Text Type: N, H10
[48116974]
The report is of an individual presenting with an exposure and an infection. The anterior portion of the implant was removed and covered with a scleral patch graft. The physician assumes that the infection occurred because of the exposure. The implant is now stable and the patient is infection free.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027377-2011-00003 |
| MDR Report Key | 2265528 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2011-09-23 |
| Date of Report | 2011-08-30 |
| Date of Event | 2008-09-01 |
| Date Mfgr Received | 2011-08-30 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2011-09-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NATALIE KENNEL, CONSULTANT |
| Manufacturer Street | 11230 SORRENTO VALLEY ROAD SUITE 135 |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8587050350 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COATED BIO-EYE HA IMPLANT |
| Generic Name | IMPLANT, EYE SPHERE |
| Product Code | HPZ |
| Date Received | 2011-09-23 |
| Model Number | I0020C |
| Lot Number | 54304 |
| Device Expiration Date | 2011-12-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRATED ORBITAL IMPLANTS |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-09-23 |