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U.S. Department of Health and Human Services

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

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SOUTHMEDIC INC. SOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL Back to Search Results
Model Number 73-0211
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem Injury (2348)
Event Date 11/26/2019
Event Type  Injury  
Manufacturer Narrative
The manufacturer was notified on 12/13/2019 by the distributor of a complaint against scalpel 73-0211. They advised that their alert date was (b)(6) 2019 and they have not yet received samples. Should samples be received from the distributor, southmedic shall evaluate them for further investigation. Review of batch records demonstrate that part is within specifications. The submission delay of this report is explained in attachment 1.
 
Event Description
As medical resident went to remove clear pvc cover to scalpel, it was stiff and required extra force and during removal, sliced his fingers. Resident very cautious to use kit now and hospital now providing a swanmorton single use scalpel - which does not have a cover over it.
 
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Brand NameSOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL
Type of DeviceSCALPEL
Manufacturer (Section D)
SOUTHMEDIC INC.
50 alliance blvd
barrie, L4M 5 K3
CA L4M 5K3
Manufacturer (Section G)
SOUTHMEDIC INC.
50 alliance blvd.
barrie, L4M 5 K3
CA L4M 5K3
Manufacturer Contact
tish whitehead
50 alliance blvd.
barrie, ontario L4M 5-K3
CA   L4M 5K3
MDR Report Key9750917
MDR Text Key180807108
Report Number8022032-2019-00005
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 Non-Healthcare Professional
Type of Report Initial
Report Date 01/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number73-0211
Device Catalogue Number73-0211
Device Lot Number102918
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2020 Patient Sequence Number: 1
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