MAUDE Adverse Event Report: BARD-PARKER ASPEN SURGICAL-A HILL ROM COMPANY BARD-PARKER SCALPEL BLADE

Lot Number 0127941

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

Bard-parker # 11 blade broke during surgical incision.Half pf blade remained in handle, other half was removed from surgical incision.

• Brand Name: BARD-PARKER SCALPEL BLADE
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): BARD-PARKER ASPEN SURGICAL-A HILL ROM COMPANY; caledonia MI 49316
• MDR Report Key: 7137479
• MDR Text Key: 95496717
• Report Number: MW5074140
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2017

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: 0127941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2017
• 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: 59 YR