MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-21 for VECTRA GENISYS 2761 manufactured by Chattanooga Group.
[801335]
Clinician conducted electrotherapy treatment on the lower back. The patient completed the 8 minute treatment and the clinician stopped the treatment. The clinician did not note any burns post-treatment. Later that evening, the pt's spouse noted a burn spot in the electrotherapy treatment area. The pt suffered a 2nd to 3rd degree burn, 1 cm in diameter, in the treatment area of the electrodes. The pt did not require any immediate or known post medical treatment for the burns. The patient has rec'd electrotherapy treatments (5) prior to this incident. The clinician treated the pt using combo treatment consisting of electrotherapy and ultrasound. The treatment time was set for 8 minutes. The ultrasound treatment setting was 1. 2 cm squared, continuous duty cycle. The remaining treatment parameters, voltage/current, frequency and intensity could not be provided by the attending clinician. The electrodes were previously used on the pt. The electrodes were uni-patch/durastick electrodes. The clinician indicated that the pt was holding the pt switch. The clinician did not indicate any changes in the treatment settings. The pt does not have any pre-existing conditions of sensitive skin, as reported by the clinician.
Patient Sequence No: 1, Text Type: D, B5
[7989989]
Awaiting unit return and evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00045 |
| MDR Report Key | 1006103 |
| Report Source | 05 |
| Date Received | 2008-02-21 |
| Date of Report | 2008-02-15 |
| Date of Event | 2007-04-01 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2008-05-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VECTRA GENISYS |
| Generic Name | POWER MUSCLE STIMULATOR |
| Product Code | LIH |
| Date Received | 2008-02-21 |
| Model Number | 2761 |
| Catalog Number | 2761 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1002833 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-02-21 |