MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC BARD-PARKER SAFETY SCALPEL; BLADE, SCALPEL

Model Number 0086

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/24/2020

Event Type  malfunction  

Event Description

15 blade broke off and tip remained inside patient.

• Brand Name: BARD-PARKER SAFETY SCALPEL
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC; 6945 southbelt dr. s.e.; caledonia MI 49316
• MDR Report Key: 10114027
• MDR Text Key: 193628054
• Report Number: 10114027
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25915 DA