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

Catalog Number 37115

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/09/2020

Event Type  malfunction  

Event Description

Two blades found in package.There should be one for count purposes.

• Brand Name: BARD-PARKER
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt drive s.e.; caledonia MI 49316
• MDR Report Key: 10477149
• MDR Text Key: 205145534
• Report Number: 10477149
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 37115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2020
• Type of Device Usage: N
• Patient Sequence Number: 1