RESTORELLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-11-27 for RESTORELLE manufactured by Coloplast A/s.

MAUDE Entry Details

Report Number2125050-2019-00997
MDR Report Key9386481
Report SourceOTHER
Date Received2019-11-27
Date of Report2019-11-06
Date Mfgr Received2019-10-28
Date Added to Maude2019-11-27
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 ContactLAUREN PRIOLEAU
Manufacturer Street1601 WEST RIVER ROAD NORTH
Manufacturer CityMINNEAPOLIS MN 55411
Manufacturer CountryUS
Manufacturer Postal55411
Manufacturer Phone6122196218
Manufacturer G1COLOPLAST MANUFACTURING US, LLC
Manufacturer Street1601 WEST RIVER ROAD NORTH
Manufacturer CityMINNEAPOLIS MN 55411
Manufacturer CountryUS
Manufacturer Postal Code55411
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRESTORELLE
Generic NameSURGICAL MESH
Product CodeOTO
Date Received2019-11-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOLOPLAST A/S
Manufacturer AddressHOLTEDAM 1 HUMLEBAEK, 3050 DA 3050


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-27

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