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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERCHTOLD CORP F628 MOBILE WITH BATTERY EXAMINATION LIGHT

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BERCHTOLD CORP F628 MOBILE WITH BATTERY EXAMINATION LIGHT Back to Search Results
Catalog Number FM 5000
Device Problem Disassembly (1168)
Patient Problem Injury (2348)
Event Date 01/17/2016
Event Type  Injury  
Manufacturer Narrative

It was reported that during the dismantling of a f628 roll stand, the spring arm kicked back and hit the user in the mouth. During the dismantle, breakdown of the product for shipment, the spring arm kicked back and hit the user in the mouth, resulting in medical intervention requiring stitches. The investigation showed that there was no product defect and the root cause was use error.

 
Event Description

It was reported that during the dismantling of a f628 roll stand, the spring arm kicked back and hit the user in the mouth. Due to the injury involved, we are filing a mdr.

 
Manufacturer Narrative

The serial number for this f628 light has been identified as (b)(4). This was missing during the initial filing.

 
Event Description

It was reported that during the dismantling of a f628 roll stand, the spring arm kicked back and hit the user in the mouth. Due to the injury involved, we are filing a mdr.

 
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Brand NameF628 MOBILE WITH BATTERY
Type of DeviceEXAMINATION LIGHT
Manufacturer (Section D)
BERCHTOLD CORP
1950 hanahan road
charleston SC 29406
Manufacturer (Section G)
BERCHTOLD CORP
1950 hanahan road
charleston SC 29406
Manufacturer Contact
adam gorzeman
1950 hanahan road
charleston, SC 29406
8435696100
MDR Report Key5435484
MDR Text Key38208536
Report Number0001220865-2016-00007
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/17/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/12/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device Catalogue NumberFM 5000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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