FDA Adverse Event
Malfunction
Summary report: N
NEEDLE ELECTRODE 3/8"
MDR report key: 1786643
·
Received June 21, 2010
Report
- Report Number
- 1044475-2010-00072
- Event Type
- Malfunction
- Date Received
- June 21, 2010
- Date of Event
- January 25, 2010
- Report Date
- May 25, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GXZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS SENT TO THE MFG SITE FOR EVAL. THE RESULTS OF THE EVAL ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS DESCRIBED AS: DURING A PROCEDURE THE NEEDLE TIP MELTED UPON ACTIVATION OF DIATHERMY MACHINE. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEEDLE ELECTRODE 3/8" | NEEDLE ELECTRODE | GXZ | TELEFLEX MEDICAL | NA | 04A0800007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |