MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; STETHOSCOPE, ADULT, STNLSS STL,GRY

Catalog Number	MDS92250
Medical Device Problem Codes	Sharp Edges (4013); Damaged Thread (4075)
Health Effect - Clinical Codes	Laceration(s) (1946); Perforation (2001)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025, the user placed the stethoscope to their ears without knowing the "ear bud had fallen off" resulting in a laceration of the left ear canal and perforated tympanic membrane.The customer stated that the user went to urgent care and an ent provider for treatment and complained of severe pain, ringing in the ear, muffled hearing, and bleeding.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2025, the user placed the stethoscope to their ears without knowing the "ear bud had fallen off" resulting in a laceration of the left ear canal and perforated tympanic membrane.The customer stated that the user went to urgent care and an ent provider for treatment and complained of severe pain, ringing in the ear, muffled hearing, and bleeding.

• Common Device Name: STETHOSCOPE, ADULT, STNLSS STL,GRY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22936859
• Report Number: 1417592-2025-00439
• Device Sequence Number: 9755222
• Product Code: LDE
• UDI-Device Identifier: 00080196326313
• UDI-Public: 00080196326313
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 09/02/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MDS92250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 09/02/2025
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 111 KG