MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-30 for THERMACHOICE III * TC013 manufactured by Ethicon, Inc..
[6054193]
Thermachoice device was opened carefully and handed to surgeon. When surgeon tried to inflate balloon an adhesion was observed which prevented the balloon from fully inflating. The device was deemed faulty and taken off the field without having any contact with patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4924432 |
| MDR Report Key | 4924432 |
| Date Received | 2015-06-30 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-06-19 |
| Report Date | 2015-06-30 |
| Date Reported to FDA | 2015-06-30 |
| Date Reported to Mfgr | 2015-07-20 |
| Date Added to Maude | 2015-07-20 |
| 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 | CATHETER, BALLOON, TRANSCERVICAL |
| Product Code | MKN |
| Date Received | 2015-06-30 |
| Model Number | * |
| Catalog Number | TC013 |
| Lot Number | HCM604 |
| ID Number | * |
| Device Availability | Y |
| 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 | 2015-06-30 |