UNKNOWN STRATTICE UNK STRATTICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-03 for UNKNOWN STRATTICE UNK STRATTICE manufactured by Lifecell.

MAUDE Entry Details

Report Number1000306051-2020-00012
MDR Report Key9780894
Report SourceCONSUMER,OTHER
Date Received2020-03-03
Date of Report2020-03-03
Date of Event2014-08-29
Date Mfgr Received2020-02-11
Date Added to Maude2020-03-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMR. CHRISTOPHER BELLE
Manufacturer Street1 MILLENNIUM WAY
Manufacturer CityBRANCHBURG NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone9089471470
Manufacturer G1LIFECELL
Manufacturer Street1 MILLENNIUM WAY
Manufacturer CityBRANCHBURG NJ 08876
Manufacturer CountryUS
Manufacturer Postal Code08876
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN STRATTICE
Generic NameMESH, SURGICAL
Product CodeFTM
Date Received2020-03-03
Catalog NumberUNK STRATTICE
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLIFECELL
Manufacturer Address1 MILLENNIUM WAY BRANCHBURG NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-03

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