MAUDE Adverse Event Report: XOMED MFG MYSTIC MEROCEL 2000 NASAL PACKING; SPLINT, INTRANASAL SEPTAL

Model Number	470404
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	10/22/2020
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 healthcare provider (hcp) reported that the patient had coughed and one of the dressings came out of his mouth and the other one they couldn't find- suspected swallowed.The hospital did a chest x-ray and could not see the dressing.Patient is able to talk and swallow so dressing is not in the esophagus.The surgeon was informed product was not harmful if swallowed.Surgeon was sent the product information document.There was no patient impact.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
Additional information received that the patient underwent surgery for nasal septal deformity and chronic sinusitis.There was no delay in the procedure.

• Brand Name: MEROCEL 2000 NASAL PACKING
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): XOMED MFG MYSTIC; 950 flanders rd; mystic CT 06355
• MDR Report Key: 10874012
• Report Number: 1219071-2020-00002
• Device Sequence Number: 11696934
• Product Code: NAB
• UDI-Device Identifier: 00681490115056
• UDI-Public: 00681490115056
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2022
• Device Model Number: 470404
• Device Catalogue Number: 470404
• Device Lot Number: 9805908
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/23/2020
• 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: Required Intervention
• Patient Age: 43 YR