FDA Adverse Event
Malfunction
Summary report: N
THERMACHOICE
MDR report key: 2192675
·
Received July 26, 2011
Report
- Report Number
- 2192675
- Event Type
- Malfunction
- Date Received
- July 26, 2011
- Date of Event
- July 25, 2011
- Report Date
- July 26, 2011
- Manufacturer
- ETHICON ATTN: ETHICON WOMEN'S HEALTH AND UROLOGY
- Product Code
- MNB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE NOTE STATES THE ERROR CODE ACCORDING TO THE MFR ERROR CODE LIST AND THE 65XX ERROR CODES STATE TO MAKE SURE THE CORRECT SOLUTION WAS BEING USED AND IF SO TO REPLACE THE CATHETER. IT WAS VERIFIED WITH THE STAFF THAT THE FLUID WAS CORRECT WHEN THE CATHETER WAS REPLACED AND THE UNIT WORKED FINE. CALLED MFR AND SPOKE TO (B)(4), TO VERIFY BASED ON WHAT I HAD TOLD HIM, THE PROBLEM WAS MOST LIKELY THE CATHETER. THE MFR REQUESTED THE CATHETER TO BE RETURNED TO THEM IF WE STILL HAVE IT. WE FOUND THAT IT WILL GO TO THE HOSPITAL RISK MANAGER. I WILL PROVIDE HIM WITH THE MFR CONTACT FOR THE RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMACHOICE | THERMACHOICE III | MNB | ETHICON ATTN: ETHICON WOMEN'S HEALTH AND UROLOGY | $$0513TC003DEMG011 | DEMG01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |