MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-13 for GYNECARE THERMACHOICE BALLOON TC003 manufactured by Ethicon.
[2015894]
The thermachoice device had a hole in the bag near the top and would not hold pressure. It was removed from the field and replaced with another of the same product. The case was completed with same machine without further problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2137275 |
| MDR Report Key | 2137275 |
| Date Received | 2011-06-13 |
| Date of Report | 2011-06-13 |
| Date of Event | 2011-05-17 |
| Report Date | 2011-06-13 |
| Date Reported to FDA | 2011-06-13 |
| Date Added to Maude | 2011-06-22 |
| 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 |
| 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 BALLOON |
| Generic Name | UTERINE BALLOON |
| Product Code | MKN |
| Date Received | 2011-06-13 |
| Model Number | TC003 |
| Catalog Number | TC003 |
| Lot Number | CMMG12 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 18 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON |
| Manufacturer Address | RT. 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-13 |