MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-03 for GYNECARE THERMACHOICE III UTERINE BALLOON * TC013 manufactured by Ethicon, Inc..
[5675500]
The surgeon was about to use the thermachoice iii uterine balloon therapy on the patient. Prior to use on the patient, the surgical technician tested the device inflating the balloon with 20 cc's of dextrose and discovered that the balloon was leaking. The device did not touch the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4680306 |
| MDR Report Key | 4680306 |
| Date Received | 2015-04-03 |
| Date of Report | 2015-04-03 |
| Date of Event | 2015-03-04 |
| Report Date | 2015-04-03 |
| Date Reported to FDA | 2015-04-03 |
| Date Reported to Mfgr | 2015-04-10 |
| Date Added to Maude | 2015-04-10 |
| 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 | GYNECARE THERMACHOICE III UTERINE BALLOON |
| Generic Name | CATHETER, BALLOON, TRANSCERVICAL |
| Product Code | MKN |
| Date Received | 2015-04-03 |
| Model Number | * |
| Catalog Number | TC013 |
| Lot Number | HAMG09 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-03 |