FDA Adverse Event
Other
Summary report: N
INTELECT XT 2CH COMBO
MDR report key: 2278725
·
Received October 3, 2011
Report
- Report Number
- 9616086-2011-00122
- Event Type
- Other
- Date Received
- October 3, 2011
- Report Date
- September 30, 2011
- Manufacturer
- DJ ORTHOPEDICS DE MEXICO
- Product Code
- GZJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
CLINICIAN CLAIMED THAT PATIENTS WERE BURNED UNDER THE ELECTRODES DURING THERAPY. EVALUATION OF THE ACTUAL DEVICE USED, EXHIBITED THAT CH2 OUTPUT CURRENT WAS "BELOW" SPECIFICATION AND THE 5 CM APPLICATOR GO NO OUTPUT READING ON EITHER FREQUENCY WHEN SET TO 10 WATTS. NEITHER CONDITION WOULD CREATE A SITUATION WHERE PATIENT WOULD RECEIVE BURNS UNDER THE ELECTRODE. POSSIBLE CAUSE OF EVENT COULD BE RELATED TO POOR ADHESIVE ATTRIBUTES OF THE ELECTRODE, HOWEVER, THE ELECTRODES USED INT EH EVENT WERE NOT RETURNED FOR EVALUATION. AS SUCH IT COULD BE REASONABLE SUGGESTED THAT THE DEVICE DID LEAD TO THE REPORTED EVENT AND THIS REASONING IS THE REASON FOR THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELECT XT 2CH COMBO | ELECTROTHERAPY | GZJ | DJ ORTHOPEDICS DE MEXICO | 2760 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |