MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-18 for THERMACHOICE III GYNECARE manufactured by Ethicon.
[2139072]
Balloon has a hole, leaking fluids noticed it while filling up the balloon. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021376 |
| MDR Report Key | 2170624 |
| Date Received | 2011-07-18 |
| Date of Report | 2011-06-02 |
| Date of Event | 2011-05-24 |
| Date Added to Maude | 2011-07-25 |
| 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 | THERMAL CHOICE BALLOON KIT |
| Product Code | MKN |
| Date Received | 2011-07-18 |
| Lot Number | CLMG10 |
| ID Number | REF# TC003 |
| Device Expiration Date | 2012-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Manufacturer Address | SOMERVILLE NJ 08876015 US 08876 0151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-18 |