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

Model Number RB-SLD-S-PP

Device Problems Break (1069); Nonstandard Device (1420)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

The distributor (an intitial reporter) reported that the broken frame (ring) of the mesh of rbound hrd was explanted and the mesh was left inside so as to keep the hernia repaired.

Event Description

The patient complained of pain.It was reported that the frame (also known as a ring) of the mesh of the hernia repair device, rebound hrd, was broken.

• Brand Name: REBOUND HRD
• Type of Device: HERNIA REPAIR MESH
• Manufacturer (Section D): ARB MEDICAL, LLC; 111 cheshire lane, suite 700; minnetonka MN 55305
• Manufacturer (Section G): ARB MEDICAL, LLC; 111 cheshire lane, suite 700; minnetonka MN 55305
• Manufacturer Contact: mike afremov ; 111 cheshire lane, suite 700; minnetonka, MN 55305 ; 7633547100
• MDR Report Key: 8030141
• MDR Text Key: 126663617
• Report Number: 3005770977-2018-00007
• Device Sequence Number: 0
• Product Code: FTL
• PMA/PMN Number: K063671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: RB-SLD-S-PP
• Device Lot Number: 150043
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention