MAUDE Adverse Event Report: Productos Medline S.A. DE C.V. Medline; DBD-THORACOTOMY TRAY

Catalog Number	DYNDS1097A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: DBD-THORACOTOMY TRAY
• Manufacturer (Section D): Productos Medline S.A. DE C.V.; blvd world trade center no. 10; parque industrial; nuevo laredo, tamaulipas 88285 ; MX 88285
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50590662
• Report Number: 3004122598-2026-00089
• Device Sequence Number: 21192654
• Product Code: LRO
• UDI-Device Identifier: 10889942796229
• UDI-Public: 10889942796229
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNDS1097A
• Device Lot Number: 25EBJ008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 05/14/2025
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Male