MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-24 for GYNECARE THERMACHOICE III * TC003 manufactured by Ethicon, Inc.
[21314807]
Thermachoice balloon did not hold pressure. After inspection, it appeared there may be a pin hole leak in the balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3657319 |
| MDR Report Key | 3657319 |
| Date Received | 2014-02-24 |
| Date of Report | 2014-02-24 |
| Date of Event | 2014-02-18 |
| Report Date | 2014-02-24 |
| Date Reported to FDA | 2014-02-24 |
| Date Reported to Mfgr | 2014-03-04 |
| Date Added to Maude | 2014-03-04 |
| 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 |
| 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 | GYNECARE THERMACHOICE III |
| Generic Name | CATHETER, BALLOON, TRANSCERVICAL |
| Product Code | MKN |
| Date Received | 2014-02-24 |
| Model Number | * |
| Catalog Number | TC003 |
| Lot Number | GGMG04 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC |
| Manufacturer Address | RT. 22 WEST P.O. BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-24 |