MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; SINUS

Model Number	DYNJ900537D
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility during a sinus surgery pieces of the 'cottonoids broke off in the sinus cavity and had to be removed with forceps'.
Additional Manufacturer Narrative
According to the facility during a sinus surgery pieces of the 'cottonoids broke off in the sinus cavity and had to be removed with forceps'.The issue was discovered in the beginning of the procedure when the cottonoids were placed in the sinus cavity for hemostasis.Per the facility the pieces that had broken off had to be removed with forceps by the surgeon.According to the facility there was impact to the procedure or patient once the pieces were removed.The sample is not available to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Common Device Name: SINUS
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14380068
• Report Number: 1423395-2022-00018
• Device Sequence Number: 6527726
• Product Code: OGR
• UDI-Device Identifier: 10888277775206
• UDI-Public: 10888277775206
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

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: DYNJ900537D
• Device Catalogue Number: DYNJ900537D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 126 KG