MAUDE Adverse Event Report: SOUTHMEDIC, INC. SOUTHMEDIC SCALPEL; BLADE, SCALPEL

Lot Number W84344

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  malfunction  

Event Description

Entire box of scalpels discovered to contain debris inside of package lot w84086, lot w84344.Reference report mw5148619.

• Brand Name: SOUTHMEDIC SCALPEL
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): SOUTHMEDIC, INC.
• MDR Report Key: 18245854
• MDR Text Key: 329609592
• Report Number: MW5148620
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: W84344
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1