MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-06-29 for THERMACHOICE TC003 manufactured by Ethicon, Inc..
[20001359]
It was reported that a pt underwent an endometrial thermal ablation procedure on (b)(6) 2012. During the procedure, there was a tear in the uterus. A general surgeon was consulted for a bowel burn, however, none was found. The uterus was repaired by suturing. Additional info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[20278098]
(b)(4). Conclusion: no conclusion can be drawn at this time. Should additional info be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2012-02432 |
| MDR Report Key | 2649857 |
| Report Source | 05,06,07 |
| Date Received | 2012-06-29 |
| Date of Report | 2012-06-05 |
| Date of Event | 2012-06-04 |
| Date Facility Aware | 2012-06-04 |
| Report Date | 2012-06-05 |
| Date Mfgr Received | 2012-06-05 |
| Date Added to Maude | 2012-07-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Manufacturer Contact | DANIEL LAMONT |
| Manufacturer Street | ROUTE 22 WEST P.O. BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182708 |
| Manufacturer G1 | ETHICON, INC. - JUAREZ |
| Manufacturer Street | AVE DE LAS TORRES #7125 COL SALVARCAR |
| Manufacturer City | JUAREZ, CHIH 32580 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMACHOICE |
| Generic Name | CATHETER, BALLOON, TRANSCERVICAL |
| Product Code | MKN |
| Date Received | 2012-06-29 |
| Model Number | NA |
| Catalog Number | TC003 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | SOMERVILLE NJ 08876015 US 08876 0151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-06-29 |