MAUDE Adverse Event Report: SOUTHMEDIC INC. SOUTHMEDIC #10 STERILE DISPOSABLE SAFETY SCALPEL

Model Number 73-0610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

The cut to the finger occured when the doctor locked the scalpel guard and then attempted to open it.It was noted that the doctor does not normally use southmedic scalpels; the doctor normally uses another brand which requires the user to push forwards to open the scalpel.The guard of the southmedic scalpels lock when it is pushed forward.The doctor attempted to use a southmedic scalpel in the same manner as another brand.When the mechanism locked the doctor tried to open the guard by means unknown and in doing so they cut themselves.

Event Description

Doctor was cut on the finger while attempting to open the scalpel guard when it was in a locked position.

• Brand Name: SOUTHMEDIC #10 STERILE DISPOSABLE SAFETY SCALPEL
• Type of Device: SCALPEL
• Manufacturer (Section D): SOUTHMEDIC INC.; 50 alliance blvd.; barrie, ontario L4M5K 3; CA L4M5K3
• 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 Key: 8339083
• MDR Text Key: 136131106
• Report Number: 8022032-2019-00001
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 73-0610
• Device Lot Number: 050418
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other