MAUDE Adverse Event Report: XOMED MFG MYSTIC MEROCEL® 2000 LAMINATED KENNEDY SINUSTENT DRESSING; SPLINT, INTRANASAL SEPTAL

Model Number	470530
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Sepsis (2067)
Date of Event	09/12/2018
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 professional (hcp) reported that the patient came back to the emergency room of the facility with ecboli from the packing and splint implants.
Additional Manufacturer Narrative
(b)(4) are no longer applicable.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care professional (hcp) reported via a manufacturer representative that the patient came back with sepsis from e.Coli 5 days after the surgery.Cultures are positive for the bacteria.The hcp noted that there were no interventions performed to prevent impact or injury in association with the splint and packing during the patient's return visit to the emergency room.

• Brand Name: MEROCEL® 2000 LAMINATED KENNEDY SINUSTENT DRESSING
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): XOMED MFG MYSTIC; 950 flanders rd; mystic CT 06355
• MDR Report Key: 7964806
• Report Number: 1219071-2018-00002
• Device Sequence Number: 13811317
• Product Code: LYA
• UDI-Device Identifier: 20681490115081
• UDI-Public: 20681490115081
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 09/01/2020
• Device Model Number: 470530
• Device Catalogue Number: 470530
• Device Lot Number: 00020329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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