MAUDE Adverse Event Report: MEDTRONIC XOMED INC. EXTERNAL NASAL SPLINT - MEDIUM; SPLINT, INTRANASAL SEPTAL

Model Number	1528120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via manufacturer representative that the external nasal splint created an injury post-operatively in the place that it had been used.There was no delay in the surgical procedure.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On follow-up, it was confirmed that the injury during the rhinoplasty procedure did not come from the external nasal splint; there was no device failure or malfunction.A non medtronic abrasion device was used which caused the injury and no other product information provided.There was no explanation on how the injury was resolved and no additional intervention or actions done to the patient.There was no back up device used.

• Brand Name: EXTERNAL NASAL SPLINT - MEDIUM
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8200619
• Report Number: 1045254-2018-00734
• Device Sequence Number: 13487217
• Product Code: LYA
• UDI-Device Identifier: 00681490042192
• UDI-Public: 00681490042192
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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
• Operator of Device: Health Professional
• Device Model Number: 1528120
• Device Catalogue Number: 1528120
• Device Lot Number: 0215072839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other