MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-02 for manufactured by .
[21126225]
Contacted st. Luke's by telephone on two occasions, and calls were returned. Sent a certified letter requesting info with regards to the pt. Have not heard from them to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218813-2006-00001 |
| MDR Report Key | 787794 |
| Date Received | 2006-11-02 |
| Date Added to Maude | 2006-11-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | HQJ |
| Date Received | 2006-11-02 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 754366 |
| Baseline Brand Name | SCLERAL BUCKLE X 2 |
| Baseline Generic Name | SCLERAL BUCKLE |
| Baseline Model No | * |
| Baseline Catalog No | 240 287 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-02 |