MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER; STAINLESS STEEL BLADES SIZE 15, STERILE

Model Number 371215

Device Problems Break (1069); Dull, Blunt (2407); Detachment of Device or Device Component (2907)

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

Event Date 08/27/2014

Event Type  Injury  

Event Description

Customer states that sales rep reports, (b)(4) contacted me to alert me the blades in a lot of their custom trays are dull - in fact one broke off in a pt today.

• Brand Name: BARD-PARKER
• Type of Device: STAINLESS STEEL BLADES SIZE 15, STERILE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; caledonia MI
• Manufacturer Contact: 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 4102636
• MDR Text Key: 4717912
• Report Number: 1836161-2014-00052
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371215
• Device Lot Number: 0040343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention