MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; T&A PACK

Catalog Number	DYNJ37266I
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the "attached string broke when trying to remove it".Due to this, "have had to go down the throat to retrieve it".
Additional Manufacturer Narrative
It was reported that the "attached string broke when trying to remove it".Due to this, "have had to go down the throat to retrieve it".It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.
Additional Manufacturer Narrative
Updated date of report to 2/3/2026.(previously entered 2/2/2026).

• Brand Name: MEDLINE
• Common Device Name: T&A PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 24249048
• Report Number: 1423395-2026-00018
• Device Sequence Number: 9970331
• Product Code: OGR
• UDI-Device Identifier: 10198459116407
• UDI-Public: 10198459116407
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 02/03/2026

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
• Device Catalogue Number: DYNJ37266I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown