MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. #11 SURGICAL BLADE; BLADE, SCALPEL

Catalog Number 0291

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

#11 surgical blade broke.

• Brand Name: #11 SURGICAL BLADE
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 18237263
• MDR Text Key: 329369675
• Report Number: 18237263
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/06/2023

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 Catalogue Number: 0291
• Device Lot Number: 3702303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2023
• Date Report to Manufacturer: 11/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Male