MAUDE Adverse Event Report: SOUTHMEDIC INC. SOUTHMEDIC #11 DISPOSABLE SCALPEL NON-STERILE

Model Number 73-0211

Device Problem Positioning Problem (3009)

Patient Problem Laceration(s) (1946)

Event Date 04/17/2018

Event Type  Injury  

Event Description

Scalpel cover/guard was too tight.A doctor cut their hand while trying to remove the cover/guard during use.

• Brand Name: SOUTHMEDIC #11 DISPOSABLE SCALPEL NON-STERILE
• 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 L4M5K 3; CA L4M5K3
• Manufacturer Contact: tish whitehead ; 50 alliance blvd; barrie, ontario L4M5K-3 ; CA L4M5K3
• MDR Report Key: 7741942
• MDR Text Key: 115775988
• Report Number: 8022032-2018-00003
• 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,health profession
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• 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: 73-0211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2018
• 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
• Patient Outcome(s): Other