MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-18 for THERMACHOICE III UTERINE BALLOON TC003 manufactured by Gynecare A Division Of Ethicon, Inc..
[2608727]
Pt for endometrial ablation. Thermachoice device was used. The thermachoice device was primed and during the priming the monitor was saying to replace the catheter. We replaced the catheter and there were no further problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025136 |
| MDR Report Key | 2546268 |
| Date Received | 2012-04-18 |
| Date of Report | 2012-04-18 |
| Date of Event | 2012-04-10 |
| Date Added to Maude | 2012-04-25 |
| 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 | RISK MANAGER |
| 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 UTERINE BALLOON |
| Generic Name | THERMACHOICE III UTERINE BALLOON |
| Product Code | MKN |
| Date Received | 2012-04-18 |
| Returned To Mfg | 2012-04-19 |
| Model Number | TC003 |
| Lot Number | DCMG18 |
| Device Expiration Date | 2013-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYNECARE A DIVISION OF ETHICON, INC. |
| Manufacturer Address | SOMERVILLE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-18 |