EMBOSPHERE MICROSPHERES S220GH-003/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-08-09 for EMBOSPHERE MICROSPHERES S220GH-003/A manufactured by Biosphere Medical Sa.

MAUDE Entry Details

• Report Number: 9615728-2019-00005
• MDR Report Key: 8878701
• Report Source: COMPANY REPRESENTATIVE,USER F
• Date Received: 2019-08-09
• Date of Report: 2019-07-11
• Date of Event: 2019-07-11
• Date Mfgr Received: 2019-09-16
• Device Manufacturer Date: 2018-12-14
• Date Added to Maude: 2019-08-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. RON BOSWELL B.S.HCA, RCIS.
• Manufacturer Street: 1600 MERIT PARKWAY
• Manufacturer City: SOUTH JORDAN, UT 84095
• Manufacturer Country: US
• Manufacturer Postal: 84095
• Manufacturer Phone: 8013164906
• Manufacturer G1: BIOSPHERE MEDICAL SA
• Manufacturer Street: PARC DES NATIONS, PARIS NORD 2 383, RUE DE LA BELLE ETOILE
• Manufacturer City: 95700
• Manufacturer Country: FR
• Manufacturer Postal Code: 95700
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EMBOSPHERE MICROSPHERES
• Generic Name: MICROSPHERES
• Product Code: NAJ
• Date Received: 2019-08-09
• Returned To Mfg: 2019-07-15
• Catalog Number: S220GH-003/A
• Lot Number: X1479070
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOSPHERE MEDICAL SA
• Manufacturer Address: PARC DES NATIONS, PARIS NORD 2 383, RUE DE LA BELLE ETOILE 95700 FR 95700

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-08-09