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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN-MORTON LTD SWANN MORTON SCALPEL BLADE

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SWANN-MORTON LTD SWANN MORTON SCALPEL BLADE Back to Search Results
Model Number 0391
Device Problem Break (1069)
Patient Problem Tissue Damage (2104)
Event Date 10/26/2018
Event Type  Injury  
Manufacturer Narrative
A sample of the broken blade has been requested for further investigation. It was stated by the customer that the sample status is unknown. Furthermore, no sample was provided; therefore, device location is unknown.
 
Event Description
Blade broke during use. Tip left inside patient, causing trauma to local tissues upon removal.
 
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Brand NameSWANN MORTON
Type of DeviceSCALPEL BLADE
Manufacturer (Section D)
SWANN-MORTON LTD
penn works owlerton green
sheffield,
UK
Manufacturer (Section G)
SWANN-MORTON LTD
penn works owlerton green
sheffield,
UK
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key8099810
MDR Text Key128199303
Report Number9611194-2018-00007
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 Administrator/Supervisor
Type of Report Initial
Report Date 11/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number0391
Device Catalogue Number0391
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/23/2018 Patient Sequence Number: 1
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