MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-18 for GYNECARE TC003 manufactured by Division Of Ethicon Inc..
[34355461]
Thermachoice ablation balloon broke in use inside pt. The device was retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058694 |
| MDR Report Key | 5324307 |
| Date Received | 2015-12-18 |
| Date of Report | 2015-12-18 |
| Date of Event | 2015-12-01 |
| Date Added to Maude | 2015-12-23 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GYNECARE |
| Generic Name | UTERINE BALLOON THERAPY SYSTEM |
| Product Code | MKN |
| Date Received | 2015-12-18 |
| Model Number | TC003 |
| Lot Number | JHMG02 |
| Device Expiration Date | 2017-07-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIVISION OF ETHICON INC. |
| Manufacturer Address | ROUTE 22 WEST PO BOX 151 SOMMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-18 |