MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-02-07 for SHARPLAN MODEL 1030 C02 LASER * manufactured by Laser Industries, Ltd..
[15378814]
It has been reported that during 1994 a male pt had two ent surgical procedures, (laser assisted urula-palatoplasty) performed on him with a c02 laser. The report further indicated that the pt now experiences complications such as velopharyngeal incompetence and nasal regurgitation, which is believed to be due to the overly aggressive palatal resection of the soft palate and the sculpting of the urula by the surgeon. Therefore, the device is not believed to have caused the serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420001-1997-00001 |
| MDR Report Key | 67521 |
| Report Source | 00 |
| Date Received | 1997-02-07 |
| Date of Report | 1997-02-07 |
| Date of Event | 1994-06-13 |
| Date Mfgr Received | 1997-01-08 |
| Date Added to Maude | 1997-02-11 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHARPLAN MODEL 1030 C02 LASER |
| Generic Name | 30 WATT C02 LASER SYSTEM |
| Product Code | EWG |
| Date Received | 1997-02-07 |
| Model Number | SHARPLAN MODEL 1030 C02 LASER |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 67548 |
| Manufacturer | LASER INDUSTRIES, LTD. |
| Manufacturer Address | ATIDIM SCIENCE BASED PARK TEL AVIV IS 61131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-02-07 |