COMPEX 2540660-17

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-05-30 for COMPEX 2540660-17 manufactured by Djo, Llc.

Event Text Entries

[109530453] Complaint received that alleges " after using the compex wireless, they were experiencing prolonged muscle tension on his arms and there were veins bulging and one of his colleagues also tried the unit and ended up with the same issue and had some veins pop up. They had to physician take a look at it and concluded that there is thickening of the blood on the affected area of the arms and they had to take a medicine to reduce the thickening and relax the muscles. There was also a slight headache that was felt after using the device".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012446970-2018-00003
MDR Report Key7553078
Report SourceCONSUMER
Date Received2018-05-30
Date of Report2018-05-30
Date of Event2018-05-21
Date Added to Maude2018-05-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactWILLIAM FISHER
Manufacturer Street1460 DECISION STREET
Manufacturer CityVISTA CA 920819663
Manufacturer CountryUS
Manufacturer Postal920819663
Manufacturer G1DJO, LLC
Manufacturer Street3151 SCOTT STREET
Manufacturer CityVISTA CA 920819663
Manufacturer CountryUS
Manufacturer Postal Code920819663
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPEX
Generic NameCOMPEX WIRELESS USA 2.0 TENS COMPLETE SET
Product CodeNGX
Date Received2018-05-30
Model Number2540660-17
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1460 DECISION STREET VISTA CA 920819663 US 920819663


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-05-30

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