MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-22 for PLASTIC BALL OCULAR IMPLANT UNKNOWN manufactured by Unknown.
[19328]
The pt had enophthalmos, irritation, discharge and right lower lid entropion following repair of open globe and ocular implant 4-5 yers ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 31665 |
| MDR Report Key | 31665 |
| Date Received | 1996-02-22 |
| Date of Report | 1996-02-05 |
| Date of Event | 1996-01-29 |
| Date Facility Aware | 1996-01-29 |
| Report Date | 1996-02-05 |
| Date Reported to FDA | 1996-02-06 |
| Date Added to Maude | 1996-04-04 |
| 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 | PLASTIC BALL OCULAR IMPLANT |
| Generic Name | PLASTIC BALL OCULAR IMPLANT |
| Product Code | HQX |
| Date Received | 1996-02-22 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 4 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 32805 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-02-22 |