D
Patient 1
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.
MAUDE MDR 973781
- MDR report key
- 973781
- Report number
- 2027377-2007-00004
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-12-11
- Date received
- 2007-12-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- NATALIE KENNEL, CONSULTANT
- Address
- 12625 HIGH BLUFF DR. SAN DIEGO CA 92130 US
- Phone
- 858-858-8587
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BIO-EYE SLEEVE | MOTILITY SLEEVE | INTEGRATED ORBITAL IMPLANTS | HPZ | I00001 | N | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-12-26 | 0 | 1. R |
Event Narratives#
N
Patient 1
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.