MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-13 for SUPRAMID OR SILASTIC IMPLANT manufactured by Unknown.
[6303]
Pt suffered a blow out fracture of left eye orbit 3 yrs ago which was repaired with silicone implant. Implant didn't fuse and was removed in 1985. Second implant inserted in 1988. Pt c/o implant riding up causing irritation and pain. Implant removed and new implant inserted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 15999 |
| MDR Report Key | 15999 |
| Date Received | 1994-06-13 |
| Date of Report | 1994-06-13 |
| Date of Event | 1994-05-16 |
| Date Facility Aware | 1994-05-17 |
| Report Date | 1994-06-13 |
| Date Reported to FDA | 1994-06-19 |
| Date Added to Maude | 1994-09-12 |
| 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 | SUPRAMID OR SILASTIC IMPLANT |
| Generic Name | IMPLANT |
| Product Code | MIB |
| Date Received | 1994-06-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 15932 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-06-13 |