SEPRAFILM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-16 for SEPRAFILM manufactured by Genzyme Corporation(framingham).

MAUDE Entry Details

Report Number1220423-2019-00010
MDR Report Key8903583
Date Received2019-08-16
Date of Report2019-08-16
Date of Event2019-02-15
Date Added to Maude2019-08-16
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(FRAMINGHAM)
Manufacturer Street76 NEW YORK AVENUE
Manufacturer CityFRAMINGHAM 01701
Manufacturer CountryUS
Manufacturer Postal Code01701
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSEPRAFILM
Generic NameMCN
Product CodeMCN
Date Received2019-08-16
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGENZYME CORPORATION(FRAMINGHAM)
Manufacturer Address76 NEW YORK AVENUE FRAMINGHAM 01701 US 01701


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2019-08-16

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