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 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

As part of the investigation, southmedic evaluated retained production samples and found the samples to be within specification.The ease of difficulty of use can be a subjective measured dependent on the operator.Southmedic reached out to the distributor to share instructions on how the cover can be safely removed.

Event Description

User described slicing their finger down close the bone at their studio while trying to remove the cap.They received 5 stitches in their index finger.The cap of the disposable scalpel was tight and those that remained at the studio were equally as tight.The user felt they were dangerous due to how tight the cap is and the extent of their injury.

• 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: christine huynh ; 50 alliance blvd.; barrie, ontario L4M 5-K3 ; CA L4M 5K3
• MDR Report Key: 15815317
• MDR Text Key: 307690842
• Report Number: 8022003-2022-00004
• 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: 11/17/2022

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
• Device Lot Number: W80199
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other