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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 0291
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Type  malfunction  
Event Description
The size 11 blade broke off inside a patient. They were able to retrieve the broken piece but did not save it. The date of occurrence was not known by cardinal health.
 
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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 Key8234095
MDR Text Key132786259
Report Number9611194-2019-00002
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 Administrator/Supervisor
Type of Report Initial
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0291
Device Catalogue Number0291
Device Lot Number5061711
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2019
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 Unkown

Patient Treatment Data
Date Received: 01/10/2019 Patient Sequence Number: 1
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