MAUDE Adverse Event Report: SOPHYSA POLARIS; POLARIS ADJUSTABLE VALVE

Model Number SPVB-2010

Device Problem Component Missing (2306)

Patient Problem Hydrocephalus (3272)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

Missing ifu sent to the distributor.Missing ifu, no issue with the device.

Event Description

Missing component: the valve was delivered to (b)(6) without the ifu in spanish, only the french/english booklet.

• Brand Name: POLARIS
• Type of Device: POLARIS 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 ; 3169353500
• MDR Report Key: 6673169
• MDR Text Key: 78584636
• Report Number: 3001587388-2017-17229
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 03760124131338
• UDI-Public: 03760124131338
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K031097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SPVB-2010
• Device Catalogue Number: SPVB-2010
• Device Lot Number: D0662
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2017
• 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): Other