MAUDE Adverse Event Report: SOUTHMEDIC INC. SOUTHMEDIC #10R DISPOSABLE SCALPEL NON-STERILE

Model Number 73-0210R

Device Problem Difficult to Open or Close (2921)

Patient Problem Laceration(s) (1946)

Event Date 04/20/2022

Event Type  malfunction  

Event Description

An esthetician was in the process of removing the cover to the blade and found it hard to get off and ended up slicing her hand, resulting in 7 stitches.

• Brand Name: SOUTHMEDIC #10R DISPOSABLE SCALPEL NON-STERILE
• Type of Device: SCALPEL
• 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 Key: 14453279
• MDR Text Key: 300349896
• Report Number: 8022003-2022-00001
• 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: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 73-0210R
• Device Catalogue Number: 73-0210R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/20/2022
• 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; Hospitalization