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

Model Number DYNJ900537D

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/05/2022

Event Type  Injury  

Event 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'.

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.
• Type of Device: 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
• MDR Text Key: 291594092
• Report Number: 1423395-2022-00018
• Device Sequence Number: 1
• Product Code: OGR
• UDI-Device Identifier: 10888277775206
• UDI-Public: 10888277775206
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYNJ900537D
• Device Catalogue Number: DYNJ900537D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 126 KG