MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-20 for THERAMCHOICE * TC013 manufactured by Ethicon, Inc.
[3918771]
Balloon was leaking, surgeon noticed balloon was sticking to heating element. ====================== manufacturer response for thermachoice, theramchoice (per site reporter). ====================== ethicon will follow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3422078 |
| MDR Report Key | 3422078 |
| Date Received | 2013-08-20 |
| Date of Report | 2013-08-20 |
| Date of Event | 2013-08-16 |
| Report Date | 2013-08-20 |
| Date Reported to FDA | 2013-08-20 |
| Date Reported to Mfgr | 2013-10-22 |
| Date Added to Maude | 2013-10-22 |
| 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 | THERAMCHOICE |
| Generic Name | CATHETER |
| Product Code | MKN |
| Date Received | 2013-08-20 |
| Model Number | * |
| Catalog Number | TC013 |
| Lot Number | EPMG12 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC |
| Manufacturer Address | ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-20 |