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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN-MORTON LTD TEXTKNIFE SCALPEL

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SWANN-MORTON LTD TEXTKNIFE SCALPEL Back to Search Results
Model Number 3991
Device Problem Mechanical Problem (1384)
Patient Problem Injury (2348)
Event Date 04/17/2018
Event Type  Injury  
Event Description
A physican cut himself by trying to close a scalpel.
 
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Brand NameTEXTKNIFE
Type of DeviceSCALPEL
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 Key7599569
MDR Text Key111003102
Report Number9611194-2018-00002
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 06/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3991
Device Catalogue Number3991
Device Lot NumberUKN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/31/2018
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?
Type of Device Usage

Patient Treatment Data
Date Received: 06/13/2018 Patient Sequence Number: 1
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