MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-18 for VECTRA GENISYS 2 CH VECTRA GENISYS 2761 2761 manufactured by Chattanooga Group.
[52409987]
Patient Sequence No: 1, Text Type: N, H10
[52409988]
Patient arrived for her 4:00pm physical therapy treatment appointment. While on the sci-fit seated stepper, patient informed physical therapist of superficial wound on her l lower back/flank area that she and her son noticed late that evening a few days earlier. Patient and son reported that after physical therapy that day (~6pm), they went do some errands and went home and noticed the localized discolored area on l lower back/flank. The patient's son states they put neosporin on it and it seems to have scabbed over on the weekend; pt denied pain on or around the same area throughout the weekend. Upon inspection, the physical therapist noted a 1. 0 inch by 0. 5 inch oval shaped wound with clean edges and black slough, (-) drainage, (-) erythema on left lower back/flank region. Pt denied pain on wound or periphery upon ocular inspection and palpation around the lower back region. Review showed it is approximately around the area where the electrode pads for the interferential current modality was placed on pt's last treatment. Physical therapist called rehab manager to inform her of incident. Rehab manager arrived and inspected the area as well as interviewed the patient and son about the incident. Manufacturer response for electrical stimulator machine, vectra genisys (per site reporter): reported by mgr of rehab. Manufacturer escalated the event to the regional mgr. Currently awaiting response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5885336 |
| MDR Report Key | 5885336 |
| Date Received | 2016-08-18 |
| Date of Report | 2016-08-11 |
| Date of Event | 2016-07-13 |
| Report Date | 2016-08-11 |
| Date Reported to FDA | 2016-08-11 |
| Date Reported to Mfgr | 2016-08-11 |
| Date Added to Maude | 2016-08-18 |
| 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 GENISYS 2 CH |
| Generic Name | POWER MUSCLE STIMULATOR |
| Product Code | IPF |
| Date Received | 2016-08-18 |
| Model Number | VECTRA GENISYS 2761 |
| Catalog Number | 2761 |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | 1430 DECISION ST. VISTA, CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-18 |