CC10522Z

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-09 for CC10522Z manufactured by Boston Scientific Neuromodulation.

Event Text Entries

[182703827] A report was received that the patient experienced a localized rash at the needle site. The symptoms were red blotches, a reaction that looked like an insect bite, and itchiness weeks after the procedure. The device was not returned to bsn as it was discarded by the medical facility.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006630150-2020-01077
MDR Report Key9808660
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-09
Date of Report2020-03-09
Date of Event2019-12-20
Date Mfgr Received2020-02-16
Date Added to Maude2020-03-09
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 ContactTALAR TAHMASIAN
Manufacturer Street25155 RYE CANYON LOOP
Manufacturer CityVALENCIA CA 91355
Manufacturer CountryUS
Manufacturer Postal91355
Manufacturer Phone6619494863
Manufacturer G1BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
Manufacturer CityALAJUELA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NamePROBE, RADIOFREQUENCY LESION
Product CodeGXI
Date Received2020-03-09
Model NumberCC10522Z
Catalog NumberCC10522Z
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC NEUROMODULATION
Manufacturer Address25155 RYE CANYON LOOP VALENCIA CA 91355 US 91355


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-09

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