MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-06-22 for COATED BIO-EYE HA IMPLANT I0016C manufactured by Integrated Orbital Implants, Inc..
[1100138]
Physician reported an exposure along suture line of coated bio-eye that was implanted a year earlier.
Patient Sequence No: 1, Text Type: D, B5
[8435524]
Exposure is an anticipated complication of orbital implant surgery. It is generally treated conservatively and is surgically closed only in the case of large exposures or if the wound does not spontaneously close within a reasonable time period. In this instance the physician contacted the mfr for advice, and surgical closure of the exposure was suggested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027377-2009-00001 |
| MDR Report Key | 1406699 |
| Report Source | 05 |
| Date Received | 2009-06-22 |
| Date of Report | 2009-05-29 |
| Date of Event | 2009-05-26 |
| Date Mfgr Received | 2009-05-29 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2009-06-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NATALIE KENNEL, CONSULTANT |
| Manufacturer Phone | 5852594355 |
| Manufacturer G1 | INTEGRATED ORBITAL IMPLANTS, INC. |
| Manufacturer Street | 12625 HIGH BLUFF DR |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COATED BIO-EYE HA IMPLANT |
| Generic Name | IMPLANT, EYE SPHERE |
| Product Code | HPZ |
| Date Received | 2009-06-22 |
| Model Number | I0016C |
| Lot Number | 63449 |
| Device Expiration Date | 2012-12-06 |
| 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, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-06-22 |