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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOUTHMEDIC INC. SOUTHMEDIC #10 STERILE DISPOSABLE SAFETY SCALPEL

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SOUTHMEDIC INC. SOUTHMEDIC #10 STERILE DISPOSABLE SAFETY SCALPEL Back to Search Results
Model Number 73-0610
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 01/22/2019
Event Type  Injury  
Manufacturer Narrative
The cut to the finger occured when the doctor locked the scalpel guard and then attempted to open it. It was noted that the doctor does not normally use southmedic scalpels; the doctor normally uses another brand which requires the user to push forwards to open the scalpel. The guard of the southmedic scalpels lock when it is pushed forward. The doctor attempted to use a southmedic scalpel in the same manner as another brand. When the mechanism locked the doctor tried to open the guard by means unknown and in doing so they cut themselves.
 
Event Description
Doctor was cut on the finger while attempting to open the scalpel guard when it was in a locked position.
 
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Brand NameSOUTHMEDIC #10 STERILE DISPOSABLE SAFETY SCALPEL
Type of DeviceSCALPEL
Manufacturer (Section D)
SOUTHMEDIC INC.
50 alliance blvd.
barrie, ontario L4M5K 3
CA L4M5K3
Manufacturer (Section G)
SOUTHMEDIC INC.
50 alliance blvd
barrie, ontario L4M 5 K3
CA L4M 5K3
Manufacturer Contact
tish whitehead
50 alliance blvd.
barrie, ontario L4M 5-K3
CA   L4M 5K3
MDR Report Key8339083
MDR Text Key136131106
Report Number8022032-2019-00001
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,user facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number73-0610
Device Lot Number050418
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2019
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: 02/14/2019 Patient Sequence Number: 1
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