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

Model Number 73-0211

Device Problem Difficult to Remove (1528)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

The manufacturer was notified (b)(6) 2019 that the distributor received 2 product complaints against scalpel 73-0211.They advised that their alert date was 11/01/19 and they received samples on 11/21/19.Southmedic received the samples for further investigation.The batch record was reviewed and samples were evaluated - no abnormalities were detected.This report represents the 2nd complaint.Another report has been made for the 1st complaint (8022032-2019-00003).

Event Description

Physician was cut severely when trying to remove the cover off of the scalpel.The scalpel had not been used on a patient yet.The physician went to the er for treatment.The nurse who reported stated the cover seemed difficult to remove and the incident occured when the physician applied force to remove the cover.

• Brand Name: SOUTHMEDIC #11 NON-STERILE DISPOSABLE SCALPEL
• Type of Device: SCALPEL
• Manufacturer (Section D): SOUTHMEDIC INC.; 50 alliance blvd.; barrie, L4M5K 3; CA L4M5K3
• Manufacturer (Section G): SOUTHMEDIC INC.; 50 alliance blvd.; barrie, L4M5K 3; CA L4M5K3
• Manufacturer Contact: tish whitehead ; 50 alliance blvd.; barrie, ontario LM45K-3 ; CA LM45K3
• MDR Report Key: 9750899
• MDR Text Key: 192719258
• Report Number: 8022032-2019-00004
• 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: 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: 040419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2019
• 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