1.8MM Q-FIX ALL SUTURE ANCHOR 25-1800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2019-11-29 for 1.8MM Q-FIX ALL SUTURE ANCHOR 25-1800 manufactured by Arthrocare Corp..

MAUDE Entry Details

Report Number3006524618-2019-00573
MDR Report Key9391647
Report SourceHEALTH PROFESSIONAL,STUDY,USE
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2018-06-01
Date Mfgr Received2019-10-31
Device Manufacturer Date2016-12-31
Date Added to Maude2019-11-29
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 ContactHOLLY TOPPING
Manufacturer Street7000 WEST WILLIAM CANNON DRIVE
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer Phone5123913905
Manufacturer G1ARTHROCARE CORP.
Manufacturer Street7000 W. WILLIAM CANNON
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal Code78735
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name1.8MM Q-FIX ALL SUTURE ANCHOR
Generic NameFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Product CodeMBI
Date Received2019-11-29
Catalog Number25-1800
Lot Number1178587
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerARTHROCARE CORP.
Manufacturer Address7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-29

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.