MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-09 for SHARPLAN MODEL 1041 CO2 LASER * manufactured by Laser Industries, Ltd.
[56746]
A pt experienced a 2nd degree burn, approx 1. 75 cm in diameter, in the pt's genital area after undergoing an outpatient gyn procedure with a co2 laser and its accessories. The pt was treated and discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420001-1997-00003 |
| MDR Report Key | 89788 |
| Report Source | 05,06 |
| Date Received | 1997-05-09 |
| Date of Report | 1997-05-09 |
| Date of Event | 1997-03-24 |
| Date Added to Maude | 1997-05-13 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHARPLAN MODEL 1041 CO2 LASER |
| Generic Name | 40 WATT CO2 LASER SYSTEM |
| Product Code | HHR |
| Date Received | 1997-05-09 |
| Model Number | 1041 CO2 LASER |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 88768 |
| Manufacturer | LASER INDUSTRIES, LTD |
| Manufacturer Address | ATIDIM SCIENCE BASED PARK TEL AVIV IS 61131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-05-09 |