MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; STETHOSCOPE,TEACHING,TWO-BINAURALS

Catalog Number	MDS9750
Medical Device Problem Codes	Material Integrity Problem (2978); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "these stethoscopes do not work.Our instructors and students can¿t hear out of them.".
Additional Manufacturer Narrative
A complaint was received, and the customer reported receiving medline teaching stethoscopes that will not work, and reported that instructors and students can¿t hear out of them.Medline received 5 teaching stethoscope samples in new condition and functional tested the samples by inserting the earpieces into our ears and listened for a frequency on the diaphragm side, then swiveled the head and listened for the frequency on the bell side.The complaint was confirmed; it is unclear at the moment were the defect is originating from, the device is not allowing the sound of a heartbeat to be heard.Division has been informed and will continue to monitor trends, and no trends were identified for the specified material number and its corresponding defect type.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: STETHOSCOPE,TEACHING,TWO-BINAURALS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50774986
• Report Number: 1417592-2026-40778
• Device Sequence Number: 10416409
• Product Code: LDE
• UDI-Device Identifier: 00080196720265
• UDI-Public: 00080196720265
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: MDS9750
• Device Lot Number: 65124060003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown