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U.S. Department of Health and Human Services

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

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ARB MEDICAL, LLC REBOUND HRD HERNIA REPAIR MESH Back to Search Results
Model Number RB-SLD-S-PP
Device Problems Break (1069); Nonstandard Device (1420)
Patient Problem Pain (1994)
Event Type  Malfunction  
Manufacturer Narrative

The distributor (an initial reporter) reported that the broken frame (ring) of the mesh of rebound 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.

 
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Brand NameREBOUND HRD
Type of DeviceHERNIA 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 Key8030110
MDR Text Key126225292
Report Number3005770977-2018-00008
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK063671
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation
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
Date FDA Received11/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberRB-SLD-S-PP
Device LOT Number160025
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2018
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?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/01/2018 Patient Sequence Number: 1
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