MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2011-05-17 for DPL NUVE PAIN HANDHELD SYSTEM NUVEPNSYS manufactured by Led Technologies, Llc.
[2540009]
Patient (user) reported a "low-energy shock" to the outside right knee area, while treating it with the dpl nuve for pain, after knee replacement ((b)(4)) surgery on (b)(6) 2011. User described the sensation as "a sharp, quick tingle" - no creams, lotions, or peptides had been in use: skin was dry and the relative humidity was low (the dpl nuve was approved for operation to a relative humidity of 85%). In addition, the user also reported that there were no open wounds, sores, or protruding rods/pins (from knee surgery) in the treatment area. User supplied photo's of the treatment area pointing to a small red skin spot where the alleged "shock" was received. These photos were inconclusive due to scarring from the initial knee surgery. No "shock" or other sensation was received by the test engineer while the dpl nuve system was operational and submerged under water. Electrical test results were within the original (b)(4), and (b)(4) test specifications. No problem found or indicated with the users dpl nuve system.
Patient Sequence No: 1, Text Type: D, B5
[9711914]
Initial use of the device caused no adverse sensations according to the user. Event may have been the result of increased blood flow circulation, and peripheral nerve stimulation after several treatment sessions with the dpl nuve system. Follow-up on (b)(6) 2011, concerning the pt's (user's) replacement dpl nuve pain system, indicated no problems to report. System works fine with no reoccurrence of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006315288-2011-00001 |
| MDR Report Key | 2458952 |
| Report Source | 00,04 |
| Date Received | 2011-05-17 |
| Date of Report | 2011-04-25 |
| Date of Event | 2011-04-20 |
| Date Mfgr Received | 2011-04-27 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2012-06-07 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SCOTT BENNETT |
| Manufacturer Street | 133 COUNTY ROAD 17, UNIT B2 |
| Manufacturer City | ELIZABETH CO 801072269 |
| Manufacturer Country | US |
| Manufacturer Postal | 801072269 |
| Manufacturer Phone | 3036460543 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DPL NUVE PAIN HANDHELD SYSTEM |
| Generic Name | LED LAMP/INFRARED LAMP |
| Product Code | OHS |
| Date Received | 2011-05-17 |
| Returned To Mfg | 2011-04-22 |
| Model Number | DPL NUVE |
| Catalog Number | NUVEPNSYS |
| Lot Number | H1003 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LED TECHNOLOGIES, LLC |
| Manufacturer Address | 133 COUNTY ROAD 17, UNIT B2 ELIZABETH CO 80107226 US 80107 2269 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-17 |