INTRATEMP THERMABASIN DRAPE ITB100

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 2018-01-26 for INTRATEMP THERMABASIN DRAPE ITB100 manufactured by Microtek Medical, Inc..

Event Text Entries

[98521630] No sample was received for evaluation. The investigation for this complaint is pending a response from the supplier. A follow up report will be submitted once additional information becomes available. This is report 1 of 2.
Patient Sequence No: 1, Text Type: N, H10


[98521631] This is the 3rd product defect within the last week; 2 of which were cracks in the bottom of the drape. Of note, the 2 basins that had cracks were used in the same warmer. No patient injury or treatment was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3013401749-2018-00001
MDR Report Key7222874
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-01-26
Date of Report2018-01-30
Date Mfgr Received2018-01-30
Date Added to Maude2018-01-26
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 ContactMRS JENNIFER MRKVICKA
Manufacturer Street370 WABASHA STREET NORTH
Manufacturer CityST. PAUL MN 55102
Manufacturer CountryUS
Manufacturer Postal55102
Manufacturer Phone6512502237
Manufacturer G1MICROTEK MEDICAL, INC.
Manufacturer Street13000 DEERFIELD PARKWAY SUITE 300
Manufacturer CityALPHARETTA GA 30004
Manufacturer CountryUS
Manufacturer Postal Code30004
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTRATEMP THERMABASIN DRAPE
Generic NameFLUID WARMING AND SLUSH DRAPES
Product CodeLHC
Date Received2018-01-26
Model NumberITB100
Lot Number77263
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMICROTEK MEDICAL, INC.
Manufacturer Address13000 DEERFIELD PARKWAY SUITE 300 ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
10 2018-01-26

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