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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN-MORTON, LTD. SURGICAL SCALPEL BLADE NO.15

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SWANN-MORTON, LTD. SURGICAL SCALPEL BLADE NO.15 Back to Search Results
Model Number D6205
Device Problem Break (1069)
Patient Problem Laceration(s) (1946)
Event Date 01/07/2020
Event Type  malfunction  
Event Description
The knife blade broke as the disc space was being incised by physician and assistant was holding the nerve root retractor to protect the spinal cord. As it broke, the broken fragment tore the dura. The nerve root and csf were visible. This was repaired with duragen and fibrin glue. Fda safety report id # (b)(4).
 
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Brand NameSURGICAL SCALPEL BLADE NO.15
Type of DeviceSCALPEL BLADE
Manufacturer (Section D)
SWANN-MORTON, LTD.
owlerton green
sheffield, gb
UK
Manufacturer (Section G)
SWANN-MORTON, LTD.
owlerton green
sheffield, gb
UK
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key10894813
MDR Text Key218980666
Report Number9611194-2020-00001
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD6205
Device Lot Number3302002
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2020
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 Unkown

Patient Treatment Data
Date Received: 11/24/2020 Patient Sequence Number: 1
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