MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-18 for GYNECARE THERMACHOICE III * TC003 manufactured by Ethicon.
[2360565]
The physician was preparing to use the device and tested it on the back table. The uterine balloon inflated, but readings indicated that the balloon was not working properly when testing it prior to use. No obvious visual defects noted. Manufacturer rep was in the or suite at the time and was aware. Md decided not to use the device. Obtained a new device and had no difficulties. No patient harm. The scrub and circulator do not recall what the specific readings were. The device and packaging were saved and sent to the manufacturer for inspection/analysis. The manufacturer's rep was present in the or at the time of the event and was aware of the above. ======================manufacturer response for uterine balloon, gynecare thermachoice iii (per site reporter). ======================the manufacturer's rep was present in the or at the time of the event and is aware of what happened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2346754 |
| MDR Report Key | 2346754 |
| Date Received | 2011-11-18 |
| Date of Report | 2011-11-18 |
| Date of Event | 2011-11-04 |
| Report Date | 2011-11-18 |
| Date Reported to FDA | 2011-11-18 |
| Date Added to Maude | 2011-11-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | GYNECARE THERMACHOICE III |
| Generic Name | UTERINE BALLOON |
| Product Code | MKN |
| Date Received | 2011-11-18 |
| Model Number | * |
| Catalog Number | TC003 |
| Lot Number | DJMG05 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2011-11-18 |