MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-10 for MED-POR UNK NA manufactured by Porex Surgical, Inc..
[25902]
Pt returned to or status post enucleation with 20 mm polyethylene implant os on 8/2/96. Diagnosis of extruding orbital implant os requiring replacement with a 15 mm silicone implant and wound revision.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 38789 |
| MDR Report Key | 38789 |
| Date Received | 1996-09-10 |
| Date of Report | 1996-09-04 |
| Date of Event | 1996-08-30 |
| Date Facility Aware | 1996-09-03 |
| Report Date | 1996-09-04 |
| Date Reported to Mfgr | 1996-09-06 |
| Date Added to Maude | 1996-09-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MED-POR |
| Generic Name | EYE SPHERE WITH CONFORMER |
| Product Code | HPZ |
| Date Received | 1996-09-10 |
| Model Number | UNK |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 40024 |
| Manufacturer | POREX SURGICAL, INC. |
| Manufacturer Address | 4715 ROOSEVELT HWY COLLEGE PARK GA 303492417 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-09-10 |