FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5 72202902

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-29 for FOOTPRINT ULTRA PK SUTURE ANCHOR 5.5 72202902 manufactured by Smith & Nephew, Inc..

Event Text Entries

[186069676] It was reported that after a rotator cuff procedure with a footprint, the patient had an infection, then a follow up was performed in july to remove the anchor. The patient outcome is unknown. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219602-2020-00565
MDR Report Key9896242
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-29
Date of Report2020-03-29
Date of Event2019-07-17
Date Mfgr Received2020-03-06
Device Manufacturer Date2019-01-12
Date Added to Maude2020-03-29
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 G1SMITH & NEPHEW, INC.
Manufacturer Street130 FORBES BOULEVARD
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal Code02048
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFOOTPRINT ULTRA PK SUTURE ANCHOR 5.5
Generic NameFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Product CodeMBI
Date Received2020-03-29
Model Number72202902
Catalog Number72202902
Lot Number2025386
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.