FDA Adverse Event
Malfunction
Summary report: N
THERMACHOICE
MDR report key: 1193499
·
Received October 8, 2008
Report
- Report Number
- 2210968-2008-00956
- Event Type
- Malfunction
- Date Received
- October 8, 2008
- Date of Event
- August 19, 2008
- Report Date
- September 9, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- MKN
- PMA / PMN Number
- P970021
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION CODE: 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE IN 2008. DURING THE PROCEDURE, A HOLE WAS NOTICED IN THE BALLOON. ANOTHER CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMACHOICE | CATHETER, BALLOON, TRANSCERVICAL | MKN | ETHICON, INC. | NA | AEMG13 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |