SKINTACT F-TB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-07-04 for SKINTACT F-TB manufactured by Leonhard Lang Gmbh.

MAUDE Entry Details

Report Number8020045-2019-00017
MDR Report Key8762335
Report SourceFOREIGN,USER FACILITY
Date Received2019-07-04
Date of Report2019-07-11
Date Mfgr Received2019-06-14
Device Manufacturer Date2019-03-08
Date Added to Maude2019-07-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BURRHUS LANG
Manufacturer StreetARCHENWEG 56
Manufacturer CityINNSBRUCK, TIROL 6020
Manufacturer CountryAU
Manufacturer Postal6020
Manufacturer G1LEONHARD LANG GMBH
Manufacturer StreetARCHENWEG 56
Manufacturer CityINNSBRUCK, 6020
Manufacturer CountryAU
Manufacturer Postal Code6020
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSKINTACT
Generic NameECG ELECTRODE
Product CodeDRX
Date Received2019-07-04
Model NumberF-TB
Lot Number190308-0228
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLEONHARD LANG GMBH
Manufacturer AddressARCHENWEG 56 INNSBRUCK, 6020 AU 6020


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Other 2019-07-04

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