SET WIRELESS SP6.0 MULTILINGUAL US PLUG 2538660

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-01-07 for SET WIRELESS SP6.0 MULTILINGUAL US PLUG 2538660 manufactured by Djo, Llc.

Event Text Entries

[132264034] The device was received and a follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[132264035] It was reported that the patient started to have subtle seizures after a couple days of using the device. The patient's doctor explained to the patient that he was having epileptic seizures and advised him to stop using the device immediately. The seizures involved an involuntary slight turn on his head, blink of his eye, and then a feeling that he was about to faint. After this, he experienced headaches that could last for an hour. The device labeling states "epilepsy. If you have suspected or diagnosed epilepsy, you should follow the precautions for use recommended by your doctor. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007615436-2019-00001
MDR Report Key8223328
Report SourceFOREIGN
Date Received2019-01-07
Date of Report2019-02-13
Date of Event2018-11-30
Date Mfgr Received2019-01-17
Date Added to Maude2019-01-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactBRIAN BECKER
Manufacturer Street3151 SCOTT STREET
Manufacturer CityVISTA CA 920819663
Manufacturer CountryUS
Manufacturer Postal920819663
Manufacturer Phone7607343126
Manufacturer G1DJO TUNISIE
Manufacturer StreetZONE INDUSTRIELLE POUDRIERE 1 AOUT
Manufacturer CitySFAX SFAX 3002
Manufacturer CountryTS
Manufacturer Postal Code3002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSET WIRELESS SP6.0 MULTILINGUAL US PLUG
Generic NamePOWERED MUSCLE STIMULATOR
Product CodeNGX
Date Received2019-01-07
Returned To Mfg2018-12-27
Model Number2538660
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address3151 SCOTT STREET VISTA CA 920819663 US 920819663


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-01-07

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