INTENSITY DQ8000

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number3005170249-0170-00013
MDR Report Key6957390
Report SourceDISTRIBUTOR
Date Received2017-10-18
Date of Report2017-07-25
Date Mfgr Received2017-07-21
Device Manufacturer Date2015-12-14
Date Added to Maude2017-10-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer StreetNO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,518108
Manufacturer CitySHENZHEN, GUANGDONG 518108
Manufacturer CountryCH
Manufacturer Postal518108
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTENSITY
Generic NameCOMBINATION DEVICE - ELECTROTHERAPY/ULTRASOUND
Product CodeGZJ
Date Received2017-10-18
Model NumberDQ8000
OperatorPHYSICAL THERAPIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
Manufacturer AddressNO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,518108 SHENZHEN, GUANGDONG 518108 CH 518108


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-10-18

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