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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 Difficult to Remove (1528)
Patient Problems Laceration(s) (1946); Injury (2348)
Event Date 11/01/2019
Event Type  Injury  
Manufacturer Narrative
The manufacturer was notified (b)(6) 2019 that the distributor received 2 product complaints against scalpel 73-0211. They advised that their alert date was 11/01/19 and they received samples on 11/21/19. Southmedic received the samples for further investigation. The batch record was reviewed and samples were evaluated - no abnormalities were detected. This report represents the 2nd complaint. Another report has been made for the 1st complaint (8022032-2019-00003).
 
Event Description
Physician was cut severely when trying to remove the cover off of the scalpel. The scalpel had not been used on a patient yet. The physician went to the er for treatment. The nurse who reported stated the cover seemed difficult to remove and the incident occured when the physician applied force to remove the cover.
 
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Brand NameSOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL
Type of DeviceSCALPEL
Manufacturer (Section D)
SOUTHMEDIC INC.
50 alliance blvd.
barrie, L4M5K 3
CA L4M5K3
Manufacturer (Section G)
SOUTHMEDIC INC.
50 alliance blvd.
barrie, L4M5K 3
CA L4M5K3
Manufacturer Contact
tish whitehead
50 alliance blvd.
barrie, ontario LM45K-3
CA   LM45K3
MDR Report Key9750899
MDR Text Key192719258
Report Number8022032-2019-00004
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 Number040419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2019
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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