MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-20 for THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM * TC013 manufactured by Ehticon Inc..
[5130589]
The device was inserted into the uterus, device did not work properly. It would not heat to proper temperature. Device was replaced with new one and surgeon was able to proceed and complete procedure. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4316053 |
| MDR Report Key | 4316053 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-11-20 |
| Date of Event | 2014-11-19 |
| Report Date | 2014-11-20 |
| Date Reported to FDA | 2014-11-20 |
| Date Reported to Mfgr | 2014-12-10 |
| Date Added to Maude | 2014-12-10 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM |
| Generic Name | CATHETER, BALLOON, TRANSCERVICAL |
| Product Code | MKN |
| Date Received | 2014-11-20 |
| Model Number | * |
| Catalog Number | TC013 |
| Lot Number | GPMG06 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EHTICON INC. |
| Manufacturer Address | ROUTE 22 WEST, PO BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-20 |