MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-07-29 for HGM A01-A-K03-0-02 PLANAR F manufactured by Fisma, Inc..
[109524]
Physician rec'd exposure when the right filter to his planar f fell out of its holder. Physician stated that he did not notice the filter was missing until after completing the procedure (laser trebeculaplastie at the power setting of 600 milliwatts). He also stated that he did not receive any injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1720381-1998-00007 |
| MDR Report Key | 180826 |
| Report Source | 05,06 |
| Date Received | 1998-07-29 |
| Date of Report | 1998-06-29 |
| Date of Event | 1998-06-26 |
| Date Mfgr Received | 1998-06-26 |
| Device Manufacturer Date | 1998-05-01 |
| Date Added to Maude | 1998-08-07 |
| 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 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HGM |
| Generic Name | LASER SLIT LAMP ATTACHMENT |
| Product Code | LQJ |
| Date Received | 1998-07-29 |
| Model Number | A01-A-K03-0-02 |
| Catalog Number | PLANAR F |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 175844 |
| Manufacturer | FISMA, INC. |
| Manufacturer Address | 3959 WEST 1820 SOUTH SALT LAKE CITY UT 84104 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-29 |