SYNVISC ONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-05 for SYNVISC ONE manufactured by Genzyme Corporation(ridgefield).

MAUDE Entry Details

Report Number2246315-2020-00034
MDR Report Key9793449
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-05
Date of Report2020-03-04
Date of Event2019-12-05
Date Added to Maude2020-03-05
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 ContactDR. HEATHER SCHIAPPACASSE
Manufacturer Street55 CORPORATE DRIVE, MS 55B-220 A
Manufacturer CityBRIDGEWATER 08807
Manufacturer CountryUS
Manufacturer Postal08807
Manufacturer G1GENZYME CORPORATION(RIDGEFIELD)
Manufacturer Street1125 PLEASANTVIEW TERRACE
Manufacturer CityRIDGEFIELD 07657
Manufacturer CountryUS
Manufacturer Postal Code07657
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYNVISC ONE
Generic NameMOZ
Product CodeMOZ
Date Received2020-03-05
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENZYME CORPORATION(RIDGEFIELD)
Manufacturer Address1125 PLEASANTVIEW TERRACE RIDGEFIELD 07657 US 07657


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-05

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