THERMACHOICE * TC003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-22 for THERMACHOICE * TC003 manufactured by Ethicon, Inc..

Event Text Entries

[4634759] Thermachoice balloon would not inflate properly. Balloon appears to be sticking together x2. 3rd thermachoice balloon was opened and worked properly. Defective ones (2) placed in red bag to be picked up by rep.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number3982971
MDR Report Key3982971
Date Received2014-07-22
Date of Report2014-07-22
Date of Event2014-07-15
Report Date2014-07-22
Date Reported to FDA2014-07-22
Date Reported to Mfgr2014-08-06
Date Added to Maude2014-08-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameTHERMACHOICE
Generic NameCATHETER, BALLOON, TRANSCERVICAL
Product CodeMKN
Date Received2014-07-22
Model Number*
Catalog NumberTC003
Lot NumberHAMG14
ID Number*
OperatorPHYSICIAN
Device AvailabilityR
Device Age1 DA
Device Sequence No1
Device Event Key0
ManufacturerETHICON, INC.
Manufacturer AddressROUTE 22 WEST SOMERVILLE NJ 08876 US 08876

Device Sequence Number: 2

Brand NameTHERMACHOICE
Generic NameCATHETER, BALLOON, TRANSCERVICAL
Product CodeMKN
Date Received2014-07-22
Model Number*
Catalog NumberTC003
Lot NumberHAMG14
ID Number*
Device AvailabilityR
Device Age1 DAY
Device Sequence No2
Device Event Key0
ManufacturerETHICON, INC.
Manufacturer AddressROUTE 22 WEST SOMERVILLE NJ 08876 US 08876

Patients

Patient NumberTreatmentOutcomeDate
10 2014-07-22
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