INTENSITY 10 DIGITAL TENS DI1010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-16 for INTENSITY 10 DIGITAL TENS DI1010 manufactured by Shenzhen Dongdixin Technology Co, Ltd..

Event Text Entries

[123837194] Customer stated that his tens unit exploded while he was using it to treat his persistent neck pain. The explosion occurred at 3am on the morning of monday, (b)(6) 2018 in the bedroom of his residence. He states that he has police and fire department reports. He states that he was awakened in the wee-hours by neck pain, and proceeded to apply the leads to the painful area (the approximate sites shown in the upper pair of electrodes in option 1 of the illustration for neck pain placement which accompanied the device and instructions). He turned the time to c, and then the intensity to 12, settings he had previously used many times with considerable benefit. While he did not record the exact time he applied the device, he would estimate it to have been around 1:30am. He then started to read his recent issue of the economist, while waiting for the pain to diminish to a level where sleep was possible - bu the ensuing bang! , flash of flames and billowing, acrid smoke dashed any hope of sleep for the rest of the night! As soon as he had extinguished the flames, which he states took 30+- seconds, and opened windows to clear the room of smoke, he called 911 and the fire department responded within minutes, the police minutes later. The device was about 1/3 destroyed: what wasn't destroyed was severely scorched, and molten case and wires were blown some distance from the site of the actual explosion, 1/2 of the partially melted battery was imbedded in the carpet about 4 feet away. While he states he was only the length of the electrode wires away from the device when it blew, he was not seriously injured. He reports an "acid burn" on the lower part of his right arm, according to the fire chief. The device is currently in possession of the insurance company for investigation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012316249-2018-00054
MDR Report Key7969513
Date Received2018-10-16
Date of Report2018-10-16
Date of Event2018-10-01
Date Facility Aware2018-10-03
Report Date2018-10-16
Date Reported to FDA2018-10-16
Date Reported to Mfgr2018-10-16
Date Added to Maude2018-10-16
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTENSITY 10 DIGITAL TENS
Generic NameTENS UNIT
Product CodeGZJ
Date Received2018-10-16
Model NumberDI1010
Catalog NumberDI1010
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Manufacturer AddressNO. 3 BUILDING XILIBAIMANG XUS INDUSTRIAL ESTATE NANSHAN SHENZHEN GUANGDONG, 518108 CH 518108


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-10-16

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