UNK EL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-27 for UNK EL manufactured by Covidien.

Event Text Entries

[68401439] An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


[68401440] The customer reports two weeks ago he was at (b)(6) with chest pain. They did an ekg and applied electrodes. He arrived home at about 1:00am and went to sleep. When he woke up the electrodes were still in place. When he removed the electrodes he states? There were chemical burns at the electrode sites?. He spoke with some nurse friends from the va who told him that this would cause permanent scarring. He is currently at (b)(6) to see a nurse practitioner regarding the? Burns?. She ordered him a steroid cream for the burn.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219103-2017-05000
MDR Report Key6360795
Report SourceUSER FACILITY
Date Received2017-02-27
Date of Report2017-02-06
Date of Event2017-01-31
Date Mfgr Received2017-02-06
Date Added to Maude2017-02-27
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 Street2 LUDLOW PARK DRIVE
Manufacturer CityCHICOPEE 01022
Manufacturer CountryUS
Manufacturer Postal Code01022
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeIKD
Date Received2017-02-27
Model NumberUNK EL
Catalog NumberUNK EL
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address2 LUDLOW PARK DRIVE CHICOPEE 01022 US 01022


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-02-27

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