MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-12-26 for BIO-EYE SLEEVE I00001 manufactured by Integrated Orbital Implants.
[772348]
Physician reported, that pt received orbital implant and plastic sleeve "over 10 years ago". Pt recently presented with infection and protrusion of the plastic sleeve. Physician attributes infection to the plastic sleeve.
Patient Sequence No: 1, Text Type: D, B5
[7929918]
Infection necessitating surgery 10 years post-operatively is an unusual occurrence. Investigation of the explanted plastic sleeve found no reason for infection nor any device issue. Note: the plastic sleeve is no longer sold. Evaluation summary: the returned device was examined visually and photographically and no issues were identified. Surgeon conducted pathology evaluation and confirmed infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027377-2007-00004 |
| MDR Report Key | 973781 |
| Report Source | 05 |
| Date Received | 2007-12-26 |
| Date of Report | 2007-12-05 |
| Date of Event | 2007-12-11 |
| Date Mfgr Received | 2007-12-05 |
| Date Added to Maude | 2008-01-08 |
| 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 Street | 12625 HIGH BLUFF DR. |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal | 92130 |
| Manufacturer Phone | 8587050350 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-EYE SLEEVE |
| Generic Name | MOTILITY SLEEVE |
| Product Code | HPZ |
| Date Received | 2007-12-26 |
| Returned To Mfg | 2007-12-21 |
| Model Number | I00001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 942667 |
| Manufacturer | INTEGRATED ORBITAL IMPLANTS |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-12-26 |