MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. VOYAGER 420

Device Problem Material Separation (1562)

Patient Problems Contusion (1787); Pain (1994)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Additional info will be provided following the conclusion of the mfr's investigation.

• Brand Name: VOYAGER 420
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay st.; magog, quebec ; CA
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay st.; magog, quebec ; CA
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3723726
• MDR Text Key: 4305608
• Report Number: 9681684-2014-00003
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 12/20/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2002
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1