FDA Adverse Event
Malfunction
Summary report: N
THERMOCHOICE
MDR report key: 1612355
·
Received February 11, 2010
Report
- Report Number
- 2210968-2010-00113
- Event Type
- Malfunction
- Date Received
- February 11, 2010
- Date of Event
- January 11, 2010
- Report Date
- January 12, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- MKN
- PMA / PMN Number
- P970021
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVAL IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B) (6) 2010. DURING THE PROCEDURE, THE DEVICE LOST PRESSURE FIVE MINUTES INTO THERAPY AND THE BALLOON LOST 6CC FLUID. A HYSTEROSCOPY WAS PERFORMED WITH GOOD RESULTS. A SECOND LIKE DEVICE WAS USED WITH NO ADVERSE PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMOCHOICE | CATHETER, BALLOON, TRANSCERVICAL | MKN | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |