MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-18 for THE LEGEND HTA UNKNOWN manufactured by Boston Scientific.
[2145322]
Pt returned to clinic w/ blisters and erosions to labia, and erosions in vagina 2 days after an endometrial ablation. The leakage alarm sounded during the procedure, indicating a 10cc fluid loss in the system, situation was assessed, procedure resumed, and 10cc fluid loss alarm sounded again. The procedure was terminated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020662 |
| MDR Report Key | 2100906 |
| Date Received | 2011-05-18 |
| Date of Report | 2011-05-18 |
| Date of Event | 2011-05-02 |
| Date Added to Maude | 2011-05-26 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE LEGEND HTA |
| Generic Name | LEGEND HTA ABLATOR |
| Product Code | HHR |
| Date Received | 2011-05-18 |
| Returned To Mfg | 2011-05-13 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-18 |