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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN MORTON, LTD DEROYAL N0. 15 CARBON STERILE BLADE SCALPEL BLADE

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SWANN MORTON, LTD DEROYAL N0. 15 CARBON STERILE BLADE SCALPEL BLADE Back to Search Results
Model Number 6205
Device Problem Mechanical Problem (1384)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description
Explanation given by deroyal, blade broke in patient's foot during a procedure causing an additional procedure (fluoroscopy procedure) to locate it and remove it. Samples was discarded due to the blade being contaminated.
 
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Brand NameDEROYAL N0. 15 CARBON STERILE BLADE
Type of DeviceSCALPEL BLADE
Manufacturer (Section D)
SWANN MORTON, LTD
owlerton green
sheffield,
UK
Manufacturer (Section G)
SWANN MORTON, LTD
owlerton green
sheffield,
UK
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key7094751
MDR Text Key94097655
Report Number9611194-2017-00008
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
Type of Report Initial
Report Date 12/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6205
Device Lot Number4221707
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/06/2017
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: 12/07/2017 Patient Sequence Number: 1
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