MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number 1885078HSE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 07/17/2018

Event Type  Injury  

Manufacturer Narrative

No evaluation was performed as the device has not been returned at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare professional reported through a manufacturer representative (rep) that during case a bur was used and that it appeared that the patient had a burn on their upper lip from where the shaft of the bur was touching the patients face.Corrective measures included the immediate removal of drill and irrigation with cool sterile saline; placement of mupirocin ointment and mepilex over the burn for remainder of case, and daily wound care with bacitracin bid.It was noted that the burn was 2nd degree and they did not believe that the device was reprocessed or re-used.No additional complications were reported or anticipated as a result of the event.Additional information received from the rep indicated that the bur was being held by the analysis team at the facility.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

Additional information received stated that the event occurred when drilling the nasal bones.Medwatch form (b)(4).

• Brand Name: XPS® BLADE
• 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: uriza shums ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328405
• MDR Report Key: 7777071
• MDR Text Key: 116907361
• Report Number: 1045254-2018-00367
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00613994233233
• UDI-Public: 00613994233233
• 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,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: 1885078HSE
• Device Catalogue Number: 1885078HSE
• Device Lot Number: 0214228090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/13/2018
• Supplement Dates Manufacturer Received: 02/08/2019
• Supplement Dates FDA Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 158