MAUDE Adverse Event Report: ARB MEDICAL, LLC REBOUND HRD; HERNIA REPAIR MESH

Model Number RB-SLD-S-PP

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

No malfunctioned device was returned to us (the manufacturer), and no x-ray image of the implanted malfunctioned device was provided to us (the manufacturer).

Event Description

The patient complained of pain.The complaint mentioned that an x-ray image showed the frame (also known as the nitinol ring) of the mesh of the hernia repair device, rebound hrd, was broken, that the ring was partially withdrawn in the aim to decrease the pain., and that the breakage did not happen at the weld of the ring.

• Brand Name: REBOUND HRD
• Type of Device: HERNIA REPAIR MESH
• Manufacturer (Section D): ARB MEDICAL, LLC; 5929 baker road, suite 470; minnetonka MN 55345
• Manufacturer (Section G): ARB MEDICAL, LLC; 5929 baker road, suite 470; minnetonka MN 55345
• Manufacturer Contact: mike afremov ; 5929 baker road, suite 470; minnetonka, MN 55345 ; 7633547100
• MDR Report Key: 7134066
• MDR Text Key: 95373193
• Report Number: 3005770977-2017-00006
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00892579001171
• UDI-Public: (01)00892579001171(17)180422(10)150022
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K063671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2018
• Device Model Number: RB-SLD-S-PP
• Device Lot Number: 150022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention