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 2011-03-24 for THERMACHOICE TC003 manufactured by Ethicon, Inc..
[1945076]
It was reported that a patient underwent a hysteroscopy procedure and an endometrial thermal ablation procedure on (b)(6) 2011. After the balloon was inserted into the uterus and therapy was started, the pressure was unstable and started to go down. The balloon was removed before one minute of therapy. There may have been approximately 1/2 cc fluid deficit. Then a small hole was noticed in the upper neck of the balloon. Another like device was used with no adverse patient consequences.
Patient Sequence No: 1, Text Type: D, B5
[9185259]
Date sent to the fda: 03/23/2011. (b)(4). Conclusion: the product upon which this medwatch is based, is anticipated. Once the product is received, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2011-00321 |
| MDR Report Key | 2066614 |
| Report Source | 05,06,07 |
| Date Received | 2011-03-24 |
| Date of Report | 2011-02-21 |
| Date of Event | 2011-02-21 |
| Date Facility Aware | 2011-02-21 |
| Report Date | 2011-02-21 |
| Date Mfgr Received | 2011-02-21 |
| Date Added to Maude | 2011-05-02 |
| 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 | 2011-03-24 |
| Model Number | NA |
| Catalog Number | TC003 |
| Lot Number | CGMG08 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2011-03-24 |