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

Model Number 73-0211

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Injury (2348)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer was notified on 12/13/2019 by the distributor of a complaint against scalpel 73-0211.They advised that their alert date was (b)(6) 2019 and they have not yet received samples.Should samples be received from the distributor, southmedic shall evaluate them for further investigation.Review of batch records demonstrate that part is within specifications.The submission delay of this report is explained in attachment 1.

Event Description

As medical resident went to remove clear pvc cover to scalpel, it was stiff and required extra force and during removal, sliced his fingers.Resident very cautious to use kit now and hospital now providing a swanmorton single use scalpel - which does not have a cover over it.

• Brand Name: SOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL
• Type of Device: SCALPEL
• Manufacturer (Section D): SOUTHMEDIC INC.; 50 alliance blvd; barrie, L4M 5 K3; CA L4M 5K3
• Manufacturer (Section G): SOUTHMEDIC INC.; 50 alliance blvd.; barrie, L4M 5 K3; CA L4M 5K3
• Manufacturer Contact: tish whitehead ; 50 alliance blvd.; barrie, ontario L4M 5-K3 ; CA L4M 5K3
• MDR Report Key: 9750917
• MDR Text Key: 180807108
• Report Number: 8022032-2019-00005
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/03/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 73-0211
• Device Catalogue Number: 73-0211
• Device Lot Number: 102918
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other