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

Model Number 73-0210R

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

What: cap is tight on 73-0210r.Two users suffered injuries (cut on the hand below the pinky finger) as they were struggling to remove the cap.Part number: 73-0210r, lot number: not provided customer impact: difficulty in use.How: during use.When: during use.

• Brand Name: SOUTHMEDIC NON-STERILE DISPOSABLE SCALPEL
• 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: 7737077
• MDR Text Key: 115685313
• Report Number: 8022032-2018-00002
• 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: Other
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 73-0210R
• Device Catalogue Number: 73-0210R
• Device Lot Number: NOT PROVIDED
• Date Manufacturer Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1