MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-10-18 for INTENSITY DQ8000 manufactured by Shenzhen Dongdixin Technology Co., Ltd..
[89566818]
The device history record was examined for the subject device. There were no problems observed during the manufacturing or testing noted in the dhr. The device labeling was reviewed and found to be suitable and adequate for the device to perform its intended use. The most likely reason is that operator didn't follow the user manual and resulting in poor contact with the power cord.
Patient Sequence No: 1, Text Type: N, H10
[89566819]
A distributor ((b)(4)) states his customer (physical therapist) has had 5 patients burnt from the combination device. The patients were burned while receiving if treatment from this device. This patient is reported as having felt no discomfort during treatment. His burns are reported as having been noticed on (b)(6) 2017 from a previous treatment on (b)(6) 2017. He is reported as having sought after medical attention for this injury, and his burns are reported as having lasted until at least (b)(6) 2017. The device involved with this event was returned to (b)(4) on 7/18/2017, and evaluated on 7/19/2017 - the customer's complaint could not be duplicated from a review of the returned device. The returned device's power cord had duct tape wrapped around it on the end that plugs into the unit - the power cord made the unit randomly shut off - the returned unit was tested with a sample power cord. The device was tested for product performance, and was determined to fall within the manufacturer's specifications for stim, as defined in the product's user manual.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005170249-0170-00013 |
| MDR Report Key | 6957390 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-18 |
| Date of Report | 2017-07-25 |
| Date Mfgr Received | 2017-07-21 |
| Device Manufacturer Date | 2015-12-14 |
| Date Added to Maude | 2017-10-18 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | NO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,518108 |
| Manufacturer City | SHENZHEN, GUANGDONG 518108 |
| Manufacturer Country | CH |
| Manufacturer Postal | 518108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTENSITY |
| Generic Name | COMBINATION DEVICE - ELECTROTHERAPY/ULTRASOUND |
| Product Code | GZJ |
| Date Received | 2017-10-18 |
| Model Number | DQ8000 |
| Operator | PHYSICAL THERAPIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. |
| Manufacturer Address | NO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,518108 SHENZHEN, GUANGDONG 518108 CH 518108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-18 |