DEVON 31160495

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-07-18 for DEVON 31160495 manufactured by Covidien.

Event Text Entries

[80283234] Submit date: 07/18/2017. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


[80283235] The customer states the marking pen was leaking. The cap is filled with ink and when they removed the cap, the ink goes everywhere.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612030-2017-05125
MDR Report Key6721152
Report SourceDISTRIBUTOR
Date Received2017-07-18
Date of Report2018-01-22
Date of Event2017-06-09
Date Mfgr Received2017-06-20
Date Added to Maude2017-07-18
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 ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN
Manufacturer StreetCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL
Manufacturer CityTIJUANA 92173
Manufacturer CountryMX
Manufacturer Postal Code92173
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEVON
Generic NameMARKER, SKIN
Product CodeFZZ
Date Received2017-07-18
Model Number31160495
Catalog Number31160495
Lot Number6299110664
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA 92173 MX 92173


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-18

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