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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 0201, 0205
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 01/21/2019
Event Type  malfunction  
Event Description
Description given by healthcare facility: "broken blades in several packs". Upon requesting further information, it was stated by the healthcare facility that the type of procedure being performed at the time of the breakage was "open procedures and that "cutting tissue" was being done at the time of breakage. It was stated that 283 blades of each shape (0201, 0205) was affected. We have questioned this as it seems unprobable that this amount of blades would have been used in one procedure.
 
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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 Key8280962
MDR Text Key134362246
Report Number9611194-2019-00003
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 Non-Healthcare Professional
Type of Report Initial
Report Date 01/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0201, 0205
Device Catalogue Number0201, 0205
Device Lot Number4821710, 4891710
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2019
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 Initial

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