MAUDE Adverse Event Report: SOUTHMEDIC INC. SOUTHMEDIC #20 STERILE BLADE

Catalog Number 73-0420

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Date 09/13/2017

Event Type  Injury  

Event Description

A southmedic #20 blade ripped the pt's skin.

• Brand Name: SOUTHMEDIC #20 STERILE BLADE
• Type of Device: #20 STERILE BLADE
• Manufacturer (Section D): SOUTHMEDIC INC.; barne OH
• MDR Report Key: 6945563
• MDR Text Key: 89239485
• Report Number: 6945563
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 73-0420
• Device Lot Number: 34165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/13/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 90