MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-02 for GYNECARE THERMA CHOICE BALLOON AB manufactured by .
[3801279]
Conmed gynecare thermachoice balloon ablation wand would not reach the appropriate pressure to allow the heating mechanism to begin. The wand was removed and it was noted 5cc of fluid in the proximal end of wand was missing. A new wand was "ipended" and it did not reach appropriate pressure to allow the heating to begin. Another machine was fond and functioned appropriately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032144 |
| MDR Report Key | 3390515 |
| Date Received | 2013-10-02 |
| Date of Report | 2013-10-01 |
| Date Added to Maude | 2013-10-09 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 0 |
| 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 | GYNECARE THERMA CHOICE BALLOON AB |
| Generic Name | GYNECARE THERMA CHOICE |
| Product Code | MKN |
| Date Received | 2013-10-02 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-02 |