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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOUTHMEDIC INC. SOUTHMEDIC #11 DISPOSABLE SCALPEL NON-STERILE

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SOUTHMEDIC INC. SOUTHMEDIC #11 DISPOSABLE SCALPEL NON-STERILE Back to Search Results
Model Number 73-0211
Device Problem Positioning Problem (3009)
Patient Problem Laceration(s) (1946)
Event Date 04/17/2018
Event Type  Injury  
Event Description
Scalpel cover/guard was too tight. A doctor cut their hand while trying to remove the cover/guard during use.
 
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Brand NameSOUTHMEDIC #11 DISPOSABLE SCALPEL NON-STERILE
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 L4M5K 3
CA L4M5K3
Manufacturer Contact
tish whitehead
50 alliance blvd
barrie, ontario L4M5K-3
CA   L4M5K3
MDR Report Key7741942
MDR Text Key115775988
Report Number8022032-2018-00003
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,health profession
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number73-0211
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2018
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

Patient Treatment Data
Date Received: 08/02/2018 Patient Sequence Number: 1
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