MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-23 for THERMACHOICE BALLOON TC003 manufactured by Ethicon Inc.
[38764832]
Patient Sequence No: 1, Text Type: N, H10
[38764833]
The thermachoice handpiece with balloon failed to heat up during a d&c, hysteroscopy. The device was replaced and case was completed without delay or harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5453499 |
| MDR Report Key | 5453499 |
| Date Received | 2016-02-23 |
| Date of Report | 2016-01-07 |
| Date of Event | 2015-10-23 |
| Report Date | 2016-01-07 |
| Date Reported to FDA | 2016-01-07 |
| Date Reported to Mfgr | 2016-01-07 |
| Date Added to Maude | 2016-02-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMACHOICE BALLOON |
| Generic Name | CATHETER, BALLOON DILATION, CERVICAL |
| Product Code | MKN |
| Date Received | 2016-02-23 |
| Catalog Number | TC003 |
| Lot Number | JGMG02 |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-02-23 |