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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 Problem Injury (2348)
Event Date 10/31/2019
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 (b)(6) 2019 and they received samples on (b)(6) 2019. Southmedic received samples for further investigation on (b)(6). Batch records were reviewed and samples were evaluated - no abnormalities were detected. This report represents 1 of the 2 complaints. Another report has been made for the 2nd complaint (b)(4).
 
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 L4M5K-3
CA   L4M5K3
MDR Report Key9750894
MDR Text Key192661166
Report Number8022032-2019-00003
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 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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