MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC BARD-PARKER RIB BACK CARBON STEEL SURGICAL BLADE; BLADE, SCALPEL

Lot Number 0204656

Device Problem Failure to Cut (2587)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  malfunction  

Event Description

Surgical blades failed to cut skin when being used.

• Brand Name: BARD-PARKER RIB BACK CARBON STEEL SURGICAL BLADE
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC; 6945 southbelt dr. s.e.; caledonia MI 49316
• MDR Report Key: 10173389
• MDR Text Key: 195737500
• Report Number: 10173389
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0204656
• 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: 06/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA