MAUDE Adverse Event Report: MEDTRONIC XOMED INC. MEDTRONIC XOMED SERRATED BLADE 11CM X 4 MM; BUR, EAR, NOSE AND THROAT

Catalog Number 1884002HRC

Device Problems Break (1069); Complete Blockage (1094)

Patient Problem No Information (3190)

Event Date 12/01/2017

Event Type  malfunction  

Event Description

Blade appeared to be clogged, then it broke in half.

• Brand Name: MEDTRONIC XOMED SERRATED BLADE 11CM X 4 MM
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC. ; jacksonville FL
• MDR Report Key: 7147649
• MDR Text Key: 95940161
• Report Number: MW5074243
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 12/01/2017

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 Expiration Date: 08/11/2021
• Device Catalogue Number: 1884002HRC
• Device Lot Number: HG205H5
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2017
• 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: 63 YR
• Patient Weight: 62