INTENSITY DQ7000(MT2400)

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 2018-04-28 for INTENSITY DQ7000(MT2400) manufactured by Shenzhen Dongdixin Technology Co., Ltd.

Event Text Entries

[106829721] We checked the dhf and dmr for mt2400, no problems were found. And the device history record was examined for the subject device. There were no problems observed during the manufacturing or testing noted in the dhr. We have been following up this event and ask distributor for more information to analysis.
Patient Sequence No: 1, Text Type: N, H10


[106829722] Clinic called today stating they purchased 3 intensity ex4's from the above distributor. They state they have had multiple patients burned on all three of their devices. She is using latex free electrodes from total medical resources. She used a lower brand from them but then changed to their platinum version. Burns occurred with both. She is using the electrodes in a criss-cross pattern. (they use the electrodes between 6" on the neck and/or low back. In each case only one electrode burned the patient. ) our product manager said these electrodes are not "clinical grade" electrodes. When questioned about the intensity levels they were using i was told they do go by patient feel. None of their patients felt their intensity was too high or even realized they had a burn until an hour or two later. The wide variation of intensity they have used goes from 8-35, rarely do they go above 40. A day after the initial report she admits they do not know which device(s) burned patients as they did not keep track. The customer states the patient received a 3rd degree burn. Therapist states she always uses the preset for acute pain/4 electrodes. First our product manager said these were not clinical grade electrodes because we sell the electrodes, the brand electrodes they claim to be using. Later she recanted and said they also purchase electrodes from other manufacturers and now she isn't sure. A day after the initial report the end-user admits they do not know which device(s) burned patients as they did not keep track. The serial numbers for these devices are (b)(4). Devices (b)(4) were returned and inspected on (b)(6) 2018. The warranty seals were broken on both devices, no cosmetic defects were found, and both devices tested for product performance and determined to fall within the manufacturer's specifications as defined in the product user manual.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005170249-2018-00007
MDR Report Key7471171
Report SourceDISTRIBUTOR
Date Received2018-04-28
Date of Report2018-03-28
Date of Event2018-03-07
Date Mfgr Received2018-03-29
Date Added to Maude2018-04-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS SIPING YUAN
Manufacturer StreetBLOCK A, 5TH FLOOR, FUHUA TECH NO. 9116 BEIHUAN ROAD
Manufacturer CitySHENZHEN, GUANGDONG 518057
Manufacturer CountryCH
Manufacturer Postal518057
Manufacturer G1SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD
Manufacturer StreetNO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,NANSHAN
Manufacturer CitySHENZHEN, GUANGDONG 518108
Manufacturer CountryCH
Manufacturer Postal Code518108
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTENSITY
Generic NameELECTROTHERAPY DEVICE
Product CodeGZJ
Date Received2018-04-28
Model NumberDQ7000(MT2400)
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,NANSHAN SHENZHEN, GUANGDONG 518108 CH 518108


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-04-28

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