MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-02 for CO2 LASER 1060 * manufactured by Sharplan.
[50002]
Pt had removal of tongue lesion with co2 laser. Upon completion of procedure, pt was noted to have a 2mm burn of right upper lip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011079 |
| MDR Report Key | 80648 |
| Date Received | 1997-04-02 |
| Date of Report | 1997-03-07 |
| Date of Event | 1997-03-05 |
| Date Added to Maude | 1997-04-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CO2 LASER |
| Generic Name | CO2 LASER |
| Product Code | EWG |
| Date Received | 1997-04-02 |
| Model Number | 1060 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 80110 |
| Manufacturer | SHARPLAN |
| Manufacturer Address | 1 PEARL COURT ALLENDALE NJ 07401 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-04-02 |