MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-07 for THERMACHOICE III * TC003 manufactured by Ethicon.
[2136964]
The surgeon was priming the device for use. A leak was discovered. The device would not hold the liquid. The device was removed from use and another device was obtained for the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2159699 |
| MDR Report Key | 2159699 |
| Date Received | 2011-07-07 |
| Date of Report | 2011-07-07 |
| Date of Event | 2011-04-27 |
| Report Date | 2011-07-07 |
| Date Reported to FDA | 2011-07-07 |
| Date Added to Maude | 2011-07-12 |
| 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 | 0 |
| 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 |
| Generic Name | UTERINE BALLOON |
| Product Code | MKN |
| Date Received | 2011-07-07 |
| Model Number | * |
| Catalog Number | TC003 |
| Lot Number | DDMG01 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Manufacturer Address | ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-07 |