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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOUTHMEDIC INC. SOUTHMEDIC #10R DISPOSABLE SCALPEL NON-STERILE

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SOUTHMEDIC INC. SOUTHMEDIC #10R DISPOSABLE SCALPEL NON-STERILE Back to Search Results
Model Number 73-0210R
Device Problem Difficult to Open or Close (2921)
Patient Problem Laceration(s) (1946)
Event Date 04/20/2022
Event Type  malfunction  
Event Description
An esthetician was in the process of removing the cover to the blade and found it hard to get off and ended up slicing her hand, resulting in 7 stitches.
 
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Brand Name
SOUTHMEDIC #10R DISPOSABLE SCALPEL NON-STERILE
Type of Device
SCALPEL
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 Key14453279
MDR Text Key300349896
Report Number8022003-2022-00001
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 User Facility,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number73-0210R
Device Catalogue Number73-0210R
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/20/2022
Initial Date FDA Received05/20/2022
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 Sequence Number1
Patient Outcome(s) Other; Hospitalization;
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