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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN-MORTON LTD KEEN SCALPEL LADE

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SWANN-MORTON LTD KEEN SCALPEL LADE Back to Search Results
Model Number 5706
Device Problem Mechanical Problem (1384)
Patient Problem Injury (2348)
Event Type  Injury  
Event Description
Description given by our (b)(4) distributor: "a nurse injured herself during pull of the keen product. As you can see attached a small yellow plastic part is broken on our samples. We managed to broke it in the same way because we did not pull it down in the right way but pulling very strong without push up the level. We assume the nurse was also treating the product this wrong way" a photograph was sent by the customer showing the broken cartridge. Further communication with our customer highlighted that four nurses had been injured by the product.
 
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Brand NameKEEN
Type of DeviceSCALPEL LADE
Manufacturer (Section D)
SWANN-MORTON LTD
penn works owlerton green
sheffield, S6 2B J
UK S6 2BJ
Manufacturer (Section G)
SWANN-MORTON LTD
penn works owlerton green
sheffield, S6 2B J
UK S6 2BJ
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key7804190
MDR Text Key117829072
Report Number9611194-2018-00004
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date04/30/2013
Device Model Number5706
Device Lot Number9631804
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/22/2018 Patient Sequence Number: 1
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