QUATTRO 2.5 DQ8450

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 2017-10-17 for QUATTRO 2.5 DQ8450 manufactured by Shenzhen Dongdixin Technology Co., Ltd..

Event Text Entries

[89457865] 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 that caused burns is that user didn't follow the instructions to clean the skin surface over which electrodes are placed.
Patient Sequence No: 1, Text Type: N, H10


[89457866] A doctor called in to say he had a patient that had been burned while being treated with a quattro 2. 5 tens unit. The doctor was not with the device when he called in to report the injury. The doctor needed further explanation and clarification regarding proper use of and terminology involved with tens unit use. The doctor denies use of ice or heat with the treatment. A follow-up with the doctor on (b)(6) 2016 concluded that the user had received 3rd degree burns, and is currently receiving treatment from a dermatologist.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005170249-2017-00005
MDR Report Key6953915
Report SourceDISTRIBUTOR
Date Received2017-10-17
Date of Report2016-05-23
Date of Event2016-04-29
Date Mfgr Received2016-05-23
Device Manufacturer Date2016-06-03
Date Added to Maude2017-10-17
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 ContactMR KANG JIANPING
Manufacturer StreetBLOCK A, 5TH FLOOR, FUHUA TECH NO. 9116 BEIHUAN ROAD
Manufacturer CitySHENZHEN, GUANGDONG 518108
Manufacturer CountryCH
Manufacturer Postal518108
Manufacturer G1SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
Manufacturer StreetNO.3 BUILDING XILIBAIMANG XUSH INDUSTRIAL ESTATE,518108
Manufacturer CitySHENZHEN, GUANGDONG 518108
Manufacturer CountryCH
Manufacturer Postal Code518108
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameQUATTRO 2.5
Generic NameTENS UNIT
Product CodeGZJ
Date Received2017-10-17
Model NumberDQ8450
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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. Congenital Not Applicablenomaly; 2. Other 2017-10-17

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