MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-08 for THERMACHOICE III TC003 PN: TC003 manufactured by Gynecare Ethicon, Inc.
[5915245]
Temperature fluctuated between 75-90. Should remain around 87 degrees.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043037 |
| MDR Report Key | 4838216 |
| Date Received | 2015-06-08 |
| Date of Report | 2015-06-05 |
| Date of Event | 2015-06-05 |
| Date Added to Maude | 2015-06-12 |
| 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 | 0 |
| 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 |
| Generic Name | UTERINE BALLOON THERAPY SYSTEM |
| Product Code | MKN |
| Date Received | 2015-06-08 |
| Model Number | TC003 |
| Catalog Number | PN: TC003 |
| Lot Number | HHMG03 |
| Device Expiration Date | 2016-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYNECARE ETHICON, INC |
| Manufacturer Address | PO BOX 151 ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Brand Name | THERMACHOICE III |
| Generic Name | UTERINE BALLOON THERAPY SYSTEM |
| Product Code | MKN |
| Date Received | 2015-06-08 |
| Model Number | TC003 |
| Catalog Number | PN: TC003 |
| Lot Number | HHMG03 |
| Device Expiration Date | 2016-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GYNECARE ETHICON INC |
| Manufacturer Address | PO BOX 151 ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-08 |