MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-08-15 for HGM I60-B-K11-1-02 060 LASER ATTACHMENT manufactured by Fisma.
[20435133]
Dr using heine 060 attachment was exposed to a "flash" of reflected laser light. The procedure was interrupted, but was completed using a slit lamp. The pt was under a local anesthesia. There was no injury to the pt. The dr was examined and found to be without injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720381-2001-00004 |
| MDR Report Key | 347944 |
| Report Source | 08 |
| Date Received | 2001-08-15 |
| Date of Report | 2001-08-01 |
| Date of Event | 2001-07-31 |
| Date Mfgr Received | 2001-08-01 |
| Device Manufacturer Date | 2000-02-01 |
| Date Added to Maude | 2001-08-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DOUGLAS KANE |
| Manufacturer Street | 3959 WEST 1820 SOUTH |
| Manufacturer City | SALT LAKE CITY UT 84104 |
| Manufacturer Country | US |
| Manufacturer Postal | 84104 |
| Manufacturer Phone | 8019720500 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HGM |
| Generic Name | INDIRECT OPHTALMOSCOPE ATTACHMENT |
| Product Code | HLI |
| Date Received | 2001-08-15 |
| Model Number | I60-B-K11-1-02 |
| Catalog Number | 060 LASER ATTACHMENT |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 337263 |
| Manufacturer | FISMA |
| Manufacturer Address | 3959 WEST 1820 SOUTH SALT LAKE CITY UT 84104 US |
| Baseline Brand Name | HGM |
| Baseline Generic Name | INDIRECT OPHTHALMOSCOPE |
| Baseline Model No | I60-B-K11-1-02 |
| Baseline Catalog No | 060 LASER ATTACHMENT |
| Baseline ID | NA |
| Baseline Device Family | HGM LASER DELIVERY SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K890787 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-08-15 |