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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
Device Problems Break (1069); Device Contamination with Body Fluid (2317)
Patient Problem No Information (3190)
Event Date 10/08/2018
Event Type  malfunction  
Event Description
When we received the complaint initially of (b)(6) it was stated as "broken blade in pack". Due to the nature of this complaint it was not deemed to be an adverse reportable incident. Following communication with the healthcare facility on (b)(6) it was stated that they believed that the blade had actually broken in a procedure as they received a sample and it appeared to be contaminated with blood. We are aware that the incident has not been reported within the specified timescale; however, on initial notification of this complaint it was stated that the blade had broken in the pack.
 
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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 Key8217457
MDR Text Key132213706
Report Number9611194-2019-00001
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 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0201
Device Lot Number4821710
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/04/2019 Patient Sequence Number: 1
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