MAUDE Adverse Event Report: ARB MEDICAL, LLC REBOUND HRD; HERNIA EPAIR DEVICE

Model Number RB-SLD-LSO-PP

Device Problem Material Separation (1562)

Patient Problem Failure of Implant (1924)

Event Date 02/20/2017

Event Type  malfunction  

Event Description

A separated frame of the device was explanted.

• Brand Name: REBOUND HRD
• Type of Device: HERNIA EPAIR DEVICE
• Manufacturer (Section D): ARB MEDICAL, LLC; 5929 baker road; suite 470; minnetonka MN 55345
• Manufacturer Contact: 5929 baker road; suite 470; minnetonka, MN 55345 ; 7633547100
• MDR Report Key: 6640527
• MDR Text Key: 77743463
• Report Number: 3005770977-2017-00003
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: RB-SLD-LSO-PP
• Device Lot Number: 150021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2017
• 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): Other