MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-13 for THERMACHOICE III TC013 manufactured by Ethicon Gynecare.
[16183302]
When ethicon gynecare thermachoice iii uterine balloon therapy catheter with fluid circulation was attempted to be inflated, the balloon was "bunched up" and would not fully inflate. This was replaced with a "like" device which functioned without issue. Diagnosis or reason for use: uterine ablation. Event abated after use: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037783 |
| MDR Report Key | 4024974 |
| Date Received | 2014-08-13 |
| Date of Report | 2014-08-12 |
| Date of Event | 2014-08-12 |
| Date Added to Maude | 2014-08-21 |
| 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 |
| 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 | THERMACHOICE III |
| Generic Name | UTERINE BALLOON THERAPY |
| Product Code | MKN |
| Date Received | 2014-08-13 |
| Model Number | TC013 |
| Catalog Number | TC013 |
| Lot Number | HAMG09 |
| Device Expiration Date | 2016-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON GYNECARE |
| Manufacturer Address | SOMERVILLE 08876 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-13 |