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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMENDIA IO-FLEX MANUAL RONGEUR

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AMENDIA IO-FLEX MANUAL RONGEUR Back to Search Results
Model Number IO-MBS-7.5
Device Problem Insufficient Information (3190)
Patient Problem Nerve Damage (1979)
Event Date 06/27/2016
Event Type  Injury  
Manufacturer Narrative
There was no apparent malfunction of the device and nothing unusual observed during the procedure. It is unknown what could have led to the patient's post-op nerve deficit. The patient has not fully recovered, and it is unknown at this time if the deficit will be permanent. The patient will be monitored for improvement. Device not returned to manufacturer.
 
Event Description
Patient experiencing nerve deficit.
 
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Brand NameIO-FLEX
Type of DeviceMANUAL RONGEUR
Manufacturer (Section D)
AMENDIA
1755 west oak parkway
marietta GA 30062
Manufacturer (Section G)
AMENDIA
1755 west oak parkway
marietta GA 30062
Manufacturer Contact
bruce hooper
1755 west oak parkway
marietta, GA 30062
8777553329
MDR Report Key5890933
MDR Text Key52612758
Report Number1067095-2016-00018
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100958
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 07/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIO-MBS-7.5
Device Lot Number15474
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/19/2016 Patient Sequence Number: 1
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