MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-01-12 for HGM DIO190-100-A HGM ACCUSPOT manufactured by Fisma, Inc..
[21320379]
The "date of this report" field, b4, was mistakenly given the date from the "date of event" field, b3. The correct date for b4 for this report is 1/12/1998.
Patient Sequence No: 1, Text Type: N, H10
[22167236]
Dr reported seeing reflected laser light while operating the laser indirect ophthalmoscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720381-1997-00006 |
| MDR Report Key | 144593 |
| Report Source | 05,06 |
| Date Received | 1998-01-12 |
| Date of Report | 1997-10-15 |
| Date of Event | 1997-10-15 |
| Date Mfgr Received | 1997-10-15 |
| Device Manufacturer Date | 1994-09-01 |
| Date Added to Maude | 1998-01-21 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HGM |
| Generic Name | LASER INDIRECT OPHTHALMOSCOPE |
| Product Code | HLI |
| Date Received | 1998-01-12 |
| Model Number | DIO190-100-A |
| Catalog Number | HGM ACCUSPOT |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 140980 |
| Manufacturer | FISMA, INC. |
| Manufacturer Address | 3959 WEST 1820 SOUTH SALT LAKE CITY UT 84104 US |
| Baseline Brand Name | HGM 019 |
| Baseline Generic Name | INDIRECT OPHTHALMOSCOPE |
| Baseline Model No | DIO190-100-A |
| Baseline Catalog No | ACCUSPOT INDIRECT |
| 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 | 1. Other | 1998-01-12 |