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 2011-03-17 for THERMACHOICE TC003 manufactured by Ethicon, Inc..
[17920655]
(b)(4) - infection. Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly. This is one of two medwatches being submitted for the same patient. See also medwatch 2210968-2011-00298.
Patient Sequence No: 1, Text Type: N, H10
[18043285]
It was reported that the patient underwent an endometrial thermal ablation procedure, a sling procedure, a dilation and curettage, and a hysteroscopy procedure on (b)(6) 2011. On (b)(6) 2011, while checking the sling, the surgeon noticed a vaginal burn the length of the anterior wall of the vaginal canal which was the size of the catheter used in the procedure. The patient had a retroverted uterus and during the procedure, the surgeon had elevated the catheter against the anterior wall and put some torque on it to complete the procedure. During the procedure, there was no indication that anything had happened with the catheter. The vagina is healed as of (b)(6) 2011 but the patient experienced a foul vaginal discharge. A necrotic piece of tissue was in the cervical os, but the cervix was normal. A vaginal culture was done and metrogel was started twice daily for five days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2011-00300 |
| MDR Report Key | 2032728 |
| Report Source | 05,06,07 |
| Date Received | 2011-03-17 |
| Date of Report | 2011-02-16 |
| Date of Event | 2011-02-02 |
| Date Facility Aware | 2011-02-15 |
| Report Date | 2011-02-16 |
| Date Mfgr Received | 2011-02-16 |
| Date Added to Maude | 2011-03-31 |
| 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 | 2011-03-17 |
| Model Number | NA |
| Catalog Number | TC003 |
| Lot Number | UNK |
| 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 | 2011-03-17 |