FDA Adverse Event
Other
Summary report: N
MICROTARGETING ELECTRODE
MDR report key: 2011840
·
Received February 25, 2011
Report
- Report Number
- 3005677147-2011-00001
- Event Type
- Other
- Date Received
- February 25, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 24, 2011
- Manufacturer
- FHC, INC.
- Product Code
- GZL
- PMA / PMN Number
- K033173
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCTS WERE RETURNED FOR EVAL. THE ELECTRODES WERE AN INCORRECT ELECTRODE TYPE AND WERE 5MM SHORTER WITH A DIAMETER ABOUT 1/10TH LARGER THAN LABELED. PACKAGING WAS NOT RETURNED FOR EVAL. FHC CONSIDERS THIS AN ISOLATED INCIDENT AS THIS IS THE ONLY REPORT RECEIVED FOR THIS LOT NUMBER WITH THIS PROBLEM.
Description of Event or Problem · 1
DISTRIBUTOR REP REPORTED TO FHC QUALITY DEPARTMENT, AN INCIDENT WHERE FOUR ELECTRODES FROM THE SAME STERILE PACKAGE WERE OF A THICKNESS WHICH PREVENTED THEIR USE WITH THE INSERTION TUBE. ELECTRODES WERE PUT ASIDE AND ANOTHER PACKAGE WAS USED. THERE WAS NO PT IMPACT AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROTARGETING ELECTRODE | ELECTRODE | GZL | FHC, INC. | 561991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | MICROTARGETING DRIVE SYSTEM |