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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN MORTON, LTD. CARBON STEEL BLADE BLADE, SCALPEL

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SWANN MORTON, LTD. CARBON STEEL BLADE BLADE, SCALPEL Back to Search Results
Model Number D6201
Device Problems Break (1069); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/21/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: an internal complaint ( (b)(4)) was received regarding a scalpel (part d6201, lot 5321812) breaking during use. The investigation is ongoing at this time. When new and critical information becomes available, the report will be updated.
 
Event Description
The blades are breaking, some inside patients.
 
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Brand NameCARBON STEEL BLADE
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
SWANN MORTON, LTD.
owlerton green
sheffield, sheffield
UK
Manufacturer (Section G)
DEROYAL INDUSTRIES, INC.
1703 highway 33 south
new tazewell TN 37825
Manufacturer Contact
sarah bennett
200 debusk lane
powell, TN 37849
8653626112
MDR Report Key11195093
MDR Text Key245731341
Report Number1060680-2020-00009
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberD6201
Device Lot Number5321812
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
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 Initial

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