MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-24 for GYNECARE THERMACHOICE III * manufactured by Ethicon, Inc..
[18546147]
Upon instillation of fluid by physician, the rn observed leakage of the uterine balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3922637 |
| MDR Report Key | 3922637 |
| Date Received | 2014-06-24 |
| Date of Report | 2014-06-23 |
| Date of Event | 2014-04-10 |
| Report Date | 2014-06-23 |
| Date Reported to FDA | 2014-06-24 |
| Date Reported to Mfgr | 2014-07-09 |
| Date Added to Maude | 2014-07-09 |
| 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 | GYNECARE THERMACHOICE III |
| Generic Name | CATHETER, BALLOON, TRANSCERVICAL |
| Product Code | MKN |
| Date Received | 2014-06-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | GAMG13 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUT 22 WEST P.O. BOX 151 SUMMERVILLE NJ 08876015 US 08876 0151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-24 |