MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-02 for SURGICAL LASER TECHNOLOGY SSRH7 UNK manufactured by Surgical Laser Technologies.
[201112]
Md reported pt sustained vulvar burns during laser conization of cervix performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 299045 |
| MDR Report Key | 299045 |
| Date Received | 2000-10-02 |
| Date of Report | 2000-09-27 |
| Date of Event | 2000-08-18 |
| Date Facility Aware | 2000-09-25 |
| Report Date | 2000-09-27 |
| Date Reported to FDA | 2000-09-27 |
| Date Reported to Mfgr | 2000-09-27 |
| Date Added to Maude | 2000-10-06 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGICAL LASER TECHNOLOGY |
| Generic Name | LASER FIBER |
| Product Code | HHR |
| Date Received | 2000-10-02 |
| Model Number | SSRH7 |
| Catalog Number | UNK |
| Lot Number | 828101 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 289469 |
| Manufacturer | SURGICAL LASER TECHNOLOGIES |
| Manufacturer Address | 200 CRESSO BLVD PO BOX 880 OAKS PA 194560880 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-10-02 |