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U.S. Department of Health and Human Services

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

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ARB MEDICAL, LLC REBOUND HRD HERNIA REPAIR DEVICE Back to Search Results
Model Number RB-SLD-S-PP
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/21/2017
Event Type  malfunction  
Event Description
A separated frame of the device was explanted with no adverse patient effects.
 
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Brand NameREBOUND HRD
Type of DeviceHERNIA REPAIR 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 Key6482067
MDR Text Key72783838
Report Number3005770977-2017-00002
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRB-SLD-S-PP
Device Lot Number120061
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/11/2017 Patient Sequence Number: 1
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