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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOPHYSA SOPHY SOPHY ADJUSTABLE VALVE

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SOPHYSA SOPHY SOPHY ADJUSTABLE VALVE Back to Search Results
Device Problem Device Inoperable (1663)
Patient Problem Hydrocephalus (3272)
Event Type  malfunction  
Event Description
We were informed by one of our distributors that an sm8 valve had to be removed immediately after implantation. Our contact states that the valve was "not working at all", without giving any details regarding the incident or the context. We are currently trying to obtain further information regarding the event and the device involved, without success to this day.
 
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Brand NameSOPHY
Type of DeviceSOPHY ADJUSTABLE VALVE
Manufacturer (Section D)
SOPHYSA
5 rue guy moquet
orsay, 91400
FR 91400
Manufacturer (Section G)
SOPHYSA
5 rue guy moquet
orsay, 91400
FR 91400
Manufacturer Contact
jean-christophe audras
5 rue guy moquet
orsay, 91400
FR   91400
MDR Report Key7421250
MDR Text Key105519236
Report Number3001587388-2018-18128
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/14/2018
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 Treatment Data
Date Received: 04/11/2018 Patient Sequence Number: 1
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