HI PWR DISPOSBL GRNDING PAD DGPHP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-07-28 for HI PWR DISPOSBL GRNDING PAD DGPHP manufactured by Covidien Lp, (valleylab).

Event Text Entries

[20791130] The customer reported there were several black corrosion spots on the pads when unpacking. The pad was not used. Initial evaluation of the returned sample found the foil was degraded and the pad showed no resistance.
Patient Sequence No: 1, Text Type: D, B5


[20909454] (b)(4). The incident device has been received and is under evaluation. When the device evaluation is complete, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1717344-2011-00599
MDR Report Key2198597
Report Source01,06
Date Received2011-07-28
Date of Report2011-07-20
Date of Event2011-06-15
Date Mfgr Received2011-07-20
Device Manufacturer Date2010-10-01
Date Added to Maude2011-09-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKIM SCHWARZ, MANAGER
Manufacturer Street5920 LONGBOW DR.
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone3035306245
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHI PWR DISPOSBL GRNDING PAD
Generic NamePATIENT RETURN ELECTRODE
Product CodeODR
Date Received2011-07-28
Returned To Mfg2011-07-13
Catalog NumberDGPHP
Lot Number193939
Device Expiration Date2013-10-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN LP, (VALLEYLAB)
Manufacturer Address5920 LONGBOW DR. BOULDER CO 80301 US 80301


Patients

Patient NumberTreatmentOutcomeDate
10 2011-07-28

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