MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOSPHERE MICROSPHERES

Catalog Number S620GH, S820GH, S1020GH

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

Patient Problems Abdominal Pain (1685); Nausea (1970)

Event Date 06/11/2015

Event Type  Injury  

Manufacturer Narrative

No device is returning for evaluation.Because a lot number was not provided, a search of the device history record and complaint database could not be performed.Device is a permanent implant.

Event Description

On (b)(6) 2015, patient was treated with the device for multiple uterine myomas.(average size 70mm, 55 mm, 53 mm).On the same day, patient developed nausea and post embolization syndrome.On (b)(6) 2015, patient recovered from nausea, and on (b)(6) 2015 recovered from pain (in the abdomen).Prolongation of hospitalization (2 days) for treatment of post embolization syndrome was required by the physician.

• 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 Contact: alix fonlladosa ; parc des nations paris nord 2; 383, rue de la belle etoile; roissy en france, 95700 ; FR 95700 ; 8172529
• MDR Report Key: 5872265
• MDR Text Key: 51964368
• Report Number: 9615728-2016-00005
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: S620GH, S820GH, S1020GH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2015
• 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: 44 YR
• Patient Weight: 54