MAUDE Adverse Event Report: GYRUS ACMI, INC. REUT-BOB VENT TB .045" [ORIG ITEM: 145224] (6/PK); TUBE, TYMPANOSTOMY

Model Number	145224-ENT
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tympanostomy tube was implanted into patient that was expired with the expiration date of oct2022 after it was implanted into the patient.Follow-up indicated that the patient had an infection.Details of the patient's current condition, treatment and patient outcome were requested but not available at the time of the report.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is to provide a correction to the initial medwatch report (mdr).Further review found there was no reportable malfunction or adverse event related to the subject device captured in this complaint.The initial mdr was inadvertently submitted as an adverse event and reportable malfunction.The initial medwatch reported that an expired tube was placed and the patient experienced a subsequent infection.However, the customer confirmed that the patient did not develop an infection due to tube placement but rather that the tube was placed due to pre-existing ear infections.There was no allegation of the device causing an infection.There were no reportable malfunctions or adverse events related to the subject device captured in this complaint.

• Brand Name: REUT-BOB VENT TB .045" [ORIG ITEM: 145224] (6/PK)
• Common Device Name: TUBE, TYMPANOSTOMY
• Manufacturer (Section D): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer (Section G): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20702486
• Report Number: 1037007-2024-00011
• Device Sequence Number: 8101300
• Product Code: ETD
• UDI-Device Identifier: 00821925038967
• UDI-Public: 00821925038967
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K820362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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 Model Number: 145224-ENT
• Device Lot Number: MH504145
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 11/17/2024
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown