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

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.

• Brand Name: F628 MOBILE WITH BATTERY
• Type of Device: EXAMINATION 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 Key: 5435484
• MDR Text Key: 38208536
• Report Number: 0001220865-2016-00007
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: FM 5000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2016
• 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
• Patient Sequence Number: 1