MAUDE Adverse Event Report: SOUTHMEDIC INC. SOUTHMEDIC BLADES AND SCALPELS

Model Number 73-0211

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

[(b)(4)].

Event Description

What: a nurse has cut their hand while removing the guard on the disposable scalpel.Where: during use.How: during use.When: during use.Part number: 73-0211; lot number: 110217; how many: 1 scalpel.

• Brand Name: SOUTHMEDIC BLADES AND SCALPELS
• 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: 7737075
• MDR Text Key: 115648995
• Report Number: 8022032-2018-00000
• Device Sequence Number: 0
• Product Code: GES
• 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
• Type of Report: Initial
• Report Date: 06/25/2018

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
• Device Operator: No Information
• Device Model Number: 73-0211
• Device Lot Number: 110217
• Was Device Available for Evaluation?: No
• Device Age: 5 MO
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention