INTELECT 4CH STIM PKG 7560

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-24 for INTELECT 4CH STIM PKG 7560 manufactured by Dj Orthopedics De Mexico.

Event Text Entries

[2003741] User facility reported burn.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616086-2011-00065
MDR Report Key2103794
Report Source06
Date Received2011-05-24
Date of Report2011-05-23
Date of Event2011-04-29
Date Added to Maude2011-06-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street1430 DECISION STREET
Manufacturer CityVISTA CA 92081
Manufacturer CountryUS
Manufacturer Postal92081
Manufacturer G1DJ ORTHOPEDICS DE MEXICO
Manufacturer CityTIJUANA B.C. 22244
Manufacturer CountryMX
Manufacturer Postal Code22244
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTELECT 4CH STIM PKG
Generic NameELECTROTHERAPY
Product CodeIMI
Date Received2011-05-24
Catalog Number7560
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJ ORTHOPEDICS DE MEXICO
Manufacturer AddressTIJUANA B.C. 22244 MX 22244


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-05-24

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