MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-17 for THERMACHOICE III GYNECARE TC003 manufactured by Ethicon.
[3514238]
Defective product. Dsw was dripping out of the balloon prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030611 |
| MDR Report Key | 3184570 |
| Date Received | 2013-06-17 |
| Date of Report | 2013-06-11 |
| Date of Event | 2013-06-11 |
| Date Added to Maude | 2013-06-25 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMACHOICE III GYNECARE |
| Generic Name | NONE |
| Product Code | MKN |
| Date Received | 2013-06-17 |
| Catalog Number | TC003 |
| Lot Number | GBMG07 |
| Device Expiration Date | 2015-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Manufacturer Address | SOMERVILLE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-17 |