MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-07-28 for UNKNOWN manufactured by Unk.
[2130030]
Infection necessitating removal of the implant. Per the reporter, the pt presented to the clinic with an infection of a previously implanted orbital implant. There is no info currently available regarding the original implantation date, the brand and type of implant, or the reason for the infection. The implant was surgically removed and was replaced with a coated bio-eye.
Patient Sequence No: 1, Text Type: D, B5
[9266865]
The reporter has been on extended leave since reporting this incident. We have therefore been unable to obtain further info regarding the original implant, the infection, and the reason for removing the original implant. If add'l info relevant to the cause or outcome of this event become available we will file an add'l info report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027377-2011-00002 |
| MDR Report Key | 2187877 |
| Report Source | 05 |
| Date Received | 2011-07-28 |
| Date of Report | 2011-06-28 |
| Date of Event | 2010-05-11 |
| Date Mfgr Received | 2011-06-28 |
| Date Added to Maude | 2011-08-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NATALIE KENNEL, CONSULTANT |
| Manufacturer Street | 11230 SORRENTO VALLEY RD. STE. 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 | 3 |
| Brand Name | UNKNOWN |
| Generic Name | IMPLANT, EYE SPHERE, HPZ |
| Product Code | HPZ |
| Date Received | 2011-07-28 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-28 |