MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-30 for ENDOMETRIAL ABLATION manufactured by .
[27625626]
After the ablation she experienced weight gain of fifteen pounds, difficulty breathing, insomnia and continous vaginal spotting. She has almost continuous menstruation now.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056852 |
| MDR Report Key | 5130034 |
| Date Received | 2015-09-30 |
| Date of Report | 2015-09-30 |
| Date of Event | 2014-06-10 |
| Date Added to Maude | 2015-10-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | ENDOMETRIAL ABLATION |
| Generic Name | ENDOMETRIAL ABLATION |
| Product Code | HHR |
| Date Received | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-30 |