MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-05-29 for HGM I19-B-A01-1-00 019 ACCUSPOT manufactured by Fisma.
[206624]
Bio tech reported to fisma (hgm) that a doctor at hospital stated he had received flashback because indirect ophthalmoscope malfunctioned. The doctor was not harmed, but was upset. The procedure was completed and there was no injury to the patient. The device was returned to the factory for service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720381-2001-00001 |
| MDR Report Key | 335805 |
| Report Source | 06 |
| Date Received | 2001-05-29 |
| Date of Report | 2001-05-03 |
| Date of Event | 2001-05-01 |
| Date Mfgr Received | 2001-05-03 |
| Device Manufacturer Date | 1998-08-01 |
| Date Added to Maude | 2001-06-06 |
| 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 OPHTHALMOSCOPE |
| Product Code | HLI |
| Date Received | 2001-05-29 |
| Returned To Mfg | 2001-05-09 |
| Model Number | I19-B-A01-1-00 |
| Catalog Number | 019 ACCUSPOT |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 325149 |
| 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 | I19-B-A01-1-00 |
| Baseline Catalog No | 019 ACCUSPOT |
| 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 | 2001-05-29 |