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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOUTHMEDIC INC. SOUTHMEDIC NON-STERILE DISPOSABLE SCALPEL

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SOUTHMEDIC INC. SOUTHMEDIC NON-STERILE DISPOSABLE SCALPEL Back to Search Results
Model Number 73-0210R
Device Problem Difficult to Remove (1528)
Patient Problem Injury (2348)
Event Type  Injury  
Event Description
What: cap is tight on 73-0210r. Two users suffered injuries (cut on the hand below the pinky finger) as they were struggling to remove the cap. Part number: 73-0210r, lot number: not provided customer impact: difficulty in use. How: during use. When: during use.
 
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Brand NameSOUTHMEDIC NON-STERILE DISPOSABLE SCALPEL
Type of DeviceSCALPEL
Manufacturer (Section D)
SOUTHMEDIC INC.
50 alliance blvd
barrie, ontario L4M 5 K3
CA L4M 5K3
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 Key7737077
MDR Text Key115685313
Report Number8022032-2018-00002
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
Type of Report Initial
Report Date 06/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number73-0210R
Device Catalogue Number73-0210R
Device Lot NumberNOT PROVIDED
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 Received03/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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