MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - IPC® M5 AND M4 30K; BUR, EAR, NOSE AND THROAT

Model Number 1884070RTC

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

Device was discarded by customer and will not be returned for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that the bur got hot and he laid the bur against the patient's nose and it burned the skin.The sales representative spoke to the scrub technician after the case and felt that the bur was not seated correctly.Requests for additional information have been made with no response yet received.

• Brand Name: XPS® BUR - IPC® M5 AND M4 30K
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: angie demo ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328355
• MDR Report Key: 7304140
• MDR Text Key: 101236458
• Report Number: 1045254-2018-00078
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00643169434585
• UDI-Public: 00643169434585
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2018
• Device Model Number: 1884070RTC
• Device Catalogue Number: 1884070RTC
• Device Lot Number: 0211932923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• Date Device Manufactured: 09/08/2016
• 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): Other