MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOSPHERE MICROSPHERES

Catalog Number S820GH/JPA

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

Patient Problems Unspecified Infection (1930); Fibrosis (3167)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A review of the complaint database and device history record could not be performed since the lot number was not provided.

Event Description

The account reports uterine artery embolization was performed on an unknown date.On an unknown date, an infection developed.The cause of the infection was unknown.The patient was re-hospitalized after discharge.On (b)(6) 2017 the infection had improved and the patient had recovered.

• Brand Name: EMBOSPHERE MICROSPHERES
• Type of Device: 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, csqp ; 1600 merit parkway; south jordan, UT 94095 ; 8012531600
• MDR Report Key: 6802388
• MDR Text Key: 82979937
• Report Number: 9615728-2017-00021
• Device Sequence Number: 1
• Product Code: NAJ
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S820GH/JPA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2017
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization