COMPEX 11-2137

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-09-16 for COMPEX 11-2137 manufactured by Djo, Llc.

Event Text Entries

[21529393] Complaint received stating that the customer had "bleeding skin burn after removing one of the 2x2 electrodes on my calf. " product not returned for eval or review. No additional info received from pt and/or clinician regarding additional details of incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616086-2013-00014
MDR Report Key3354692
Report Source04
Date Received2013-09-16
Date of Report2013-09-16
Date of Event2013-08-01
Date Added to Maude2013-09-19
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 FDA3
Report to FDA0
Event Location0
Manufacturer Street1430 DECISION ST
Manufacturer CityVISTA CA 92081
Manufacturer CountryUS
Manufacturer Postal92081
Manufacturer Phone7607271280
Manufacturer G1DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
Manufacturer StreetCARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO
Manufacturer CityTIJUANA B.C. 22244
Manufacturer CountryMX
Manufacturer Postal Code22244
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPEX
Generic NameSPORT ELITE
Product CodeNGX
Date Received2013-09-16
Model Number11-2137
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1490 DECISION ST VISTA CA 92081 US 92081


Patients

Patient NumberTreatmentOutcomeDate
10 2013-09-16

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