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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOUTHMEDIC INC. SOUTHMEDIC BLADES AND SCALPELS

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SOUTHMEDIC INC. SOUTHMEDIC BLADES AND SCALPELS Back to Search Results
Model Number 73-0211
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 04/17/2018
Event Type  Injury  
Manufacturer Narrative
[(b)(4)].
 
Event Description
What: a nurse has cut their hand while removing the guard on the disposable scalpel. Where: during use. How: during use. When: during use. Part number: 73-0211; lot number: 110217; how many: 1 scalpel.
 
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Brand NameSOUTHMEDIC BLADES AND SCALPELS
Type of DeviceSCALPEL
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 Key7737075
MDR Text Key115648995
Report Number8022032-2018-00000
Device Sequence Number0
Product Code GES
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number73-0211
Device Lot Number110217
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age5 MO
Event Location No Information
Date Manufacturer Received04/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/02/2017
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: 07/31/2018 Patient Sequence Number: 0
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