MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-19 for THERMACHOICE manufactured by Ethicon.
[4941660]
Thermachoice ablation balloon discovered to have a hole in it post-procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038326 |
| MDR Report Key | 4117375 |
| Date Received | 2014-09-19 |
| Date of Report | 2014-09-19 |
| Date of Event | 2014-09-19 |
| Date Added to Maude | 2014-09-26 |
| 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 |
| 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 |
| Generic Name | THERMACHOICE ABLATION BALLOON |
| Product Code | MKN |
| Date Received | 2014-09-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Manufacturer Address | CINCINATTI 45242 45242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-19 |