MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-22 for VECTRA GENYSIS 27335 manufactured by Djo, Llc..
[60678442]
Patient Sequence No: 1, Text Type: N, H10
[60678443]
Patient was placed on electrical stimulation for 10 min. Afterwards, the patient complained of pain in his back area. The patient was noted to have 4 skin lesions, 2 cervical area and 2 lumbar area. It appears the stim unit malfunctioned causing the patient to receive more stimulation than intended. The patient has 2 small 1st degree burns just below neck, each approx 1 cm in diameter, no drainage, no red streaking, no blistering. The patient has another 2 small 1st degree burns to the lower back just above the belt line, each one is approximately 1 cm in diameter, no redness, no drainage, no blistering
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6120699 |
| MDR Report Key | 6120699 |
| Date Received | 2016-11-22 |
| Date of Report | 2016-10-07 |
| Date of Event | 2016-09-28 |
| Report Date | 2016-10-07 |
| Date Reported to FDA | 2016-10-07 |
| Date Reported to Mfgr | 2016-10-07 |
| Date Added to Maude | 2016-11-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VECTRA GENYSIS |
| Generic Name | STIMULATOR, MUSCLE, POWERED |
| Product Code | IPF |
| Date Received | 2016-11-22 |
| Model Number | 27335 |
| Catalog Number | 27335 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC. |
| Manufacturer Address | 1430 DECISION ST. VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-22 |