MAUDE Adverse Event Report: XOMED MFG MYSTIC MEROCEL® NASAL - STANDARD DRESSING; SPLINT, INTRANASAL SEPTAL

Model Number	400402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that merocel product was sterile and packaging was not damaged.The patient underwent jaw cyst surgery and merocel sponge was used by placing inside the surgical cavity on the jaw.The sponge was placed in the patient's body for about 26 hours.User informed the patient that it was used to stop bleeding.The sponge was removed by a doctor.Three weeks after the surgery, the patient face was severely swollen and infection was suspected.
Additional Manufacturer Narrative
H6: previously added imdrf d12 is no longer valid.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MEROCEL® NASAL - STANDARD DRESSING
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): XOMED MFG MYSTIC; 950 flanders rd; mystic CT 06355
• Manufacturer (Section G): XOMED MFG MYSTIC; 950 flanders rd; mystic CT 06355
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 20343973
• Report Number: 1219071-2024-00001
• Device Sequence Number: 7945388
• Product Code: LYA
• UDI-Device Identifier: 00681490105156
• UDI-Public: 00681490105156
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2024

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 Expiration Date: 10/30/2025
• Device Model Number: 400402
• Device Catalogue Number: 400402
• Device Lot Number: 11479066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 12/24/2024
• Date Device Manufactured: 10/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Prefer Not To Disclose