SILICONE II MCP IMPLANT SIZE 30 (STERILE PACKED) MCP30

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-07 for SILICONE II MCP IMPLANT SIZE 30 (STERILE PACKED) MCP30 manufactured by Stryker Gmbh.

MAUDE Entry Details

Report Number0008031020-2020-00095
MDR Report Key9558366
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-07
Date of Report2020-01-07
Date of Event2019-12-10
Date Mfgr Received2019-12-12
Date Added to Maude2020-01-07
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 ContactMR. SHARON RIVAS
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER GMBH
Manufacturer StreetBOHNACKERWEG 1 POSTFACH
Manufacturer CitySELZACH 2545
Manufacturer CountryCH
Manufacturer Postal Code2545
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSILICONE II MCP IMPLANT SIZE 30 (STERILE PACKED)
Generic NamePROSTHESIS, FINGER, CONSTRAINED, POLYMER
Product CodeKYJ
Date Received2020-01-07
Catalog NumberMCP30
Lot Number14983Y
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER GMBH
Manufacturer AddressBOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-07

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