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

Model Number 73-0610

Device Problem Fail-Safe Problem (2936)

Patient Problem Laceration(s) (1946)

Event Date 01/25/2018

Event Type  Injury  

Manufacturer Narrative

This event was initially deemed not reportable by southmedic inc.It was determined that the user did not follow instructions for retraction of the safety guard.The user facility reported the incident through the medwatch program, however this additional information was not relayed to the regulatory department at the manufacturing facility, which would have prompted a review of the reporting requirements for this incident.Efforts were made to increase awareness of reporting requirements with personnel involved in complaint handling.In (b)(4) 2018.Additional complaints were received where users cut themselves attempting to remove the guard from southmedic scalpels.The increased frequency of these complaints, and consultation with clinical experts, led to the decision that these incidences should be reported.

Event Description

Report from the user facility: "one of our physicians cut his hand trying to pull back the protective shield before use.The shield did not pull back easily using the top of the scalpel and one finger and it looks like the physician had to use his thumb and finger to grip the shield on the sides, leading to the injury." this event was reported through the fda medwatch program by the user facility under mw5075057.

• Brand Name: SOUTHMEDIC #10 STERILE SAFETY SCALPEL
• Type of Device: SAFETY 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: 7742332
• MDR Text Key: 115798372
• Report Number: 8022032-2018-00004
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 73-0610
• Device Catalogue Number: 73-0610
• Device Lot Number: 110917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2017
• 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