MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOSPHERE MICROSPHERES

Catalog Number S620GH/JPA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return.A review of the device history and complaint data base could not be reviewed since the lot number was not provided.

Event Description

Account reports that during a uterine artery myoma embolization, pain developed at the site after injecting two syringes of 500-700 microns embosphere microspheres.On (b)(6) 2017 the patients pain resolved later in the afternoon.The discharge date was postponed one day.On (b)(6) 2017 the patient was discharged from hospital.

• Brand Name: EMBOSPHERE MICROSPHERES
• Type of Device: EMBOSPHERE MICROSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; roissy en, france 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; roissy en, france 95700 ; FR 95700
• Manufacturer Contact: casey hughes ms, cqe ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6360348
• MDR Text Key: 68378423
• Report Number: 9615728-2017-00002
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: S620GH/JPA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR