MAUDE Adverse Event Report: ASPEN SURGICAL PUERTO RICO CORP. BARD PARKER/ASPEN SURGICAL #11 PROTECTED BLADE; BLADE, SCALPEL

Model Number REF 373911

Device Problem Defective Component (2292)

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

Event Date 03/16/2021

Event Type  malfunction  

Event Description

The safety blade that was opened for the procedure did not function properly - the protection over the blade would not slide open.A new blade was opened and the surgery was completed without incident.Fda safety report id# (b)(4).

• Brand Name: BARD PARKER/ASPEN SURGICAL #11 PROTECTED BLADE
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PUERTO RICO CORP.
• MDR Report Key: 13118232
• MDR Text Key: 283140404
• Report Number: MW5106369
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/27/2021

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 Expiration Date: 07/31/2023
• Device Model Number: REF 373911
• Device Lot Number: 0230370
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female