MAUDE Adverse Event Report: MDF INSTRUMENTS MEDIFRIEND INC MDF; MDF ACOUSTICA DUAL HEAD STETHOSCOPE > ADULT > BLACKOUT/ALL BLACK/MDFBO

Model Number	MDF747XPBO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Skin Burning Sensation (4540); Eczema (4547)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from the customer: "that the stethoscope tubing broke on the neck and she started to feel like a burning sensation.The customer said, "that there is rash on the neck to the chest and that she is taking medication cream for the washing on the neck." the customer also mention that "this will be the second time that the doctor had prescribe medication for the rash and the doctor suggested for the customer to get in contact with the stethoscope company.The customer mention that she had order two sleeves for the stethoscopes.".
Additional Manufacturer Narrative
The serial number provided did not match our records.Therefore conducting a record review of the finished goods lot and a warehouse inspection becomes challenging.These identifiers are crucial for tracing a product's manufacturing history, ensuring compliance with quality standards, and facilitating efficient inventory management.
Additional Manufacturer Narrative
Follow up and final report 10/28/2025.Per the individual's initial inquiry regarding whether the product contained latex, the customer was informed that the device does not contain latex or natural rubber components.A review of the device history record, material specifications and manufacturing processes, no deviations or anormalities were identidied.The device was produced in accordance with validated procedures and meets all approved design specifications.The most probable root cause could have been that the reported rash is most likely associated with individual factors, including pre-existing eczema, latex allergy, and other potential environmental influences, rather than any material or manufacturing issue.No device- related root cause was identified.No further action is required at this time.Corrections made: b-5, d-3, e-1, g-1, h-6.
Event or Problem Description
Follow up: during the customer's first phone call on (b)(6) 2025, she stated that she had developed a rash and consulted a co-worker who is a doctor.The doctor advised her to contact us to inquire about the product materials.On a second phone call on (b)(6) 2025, the supervisor contacted the customer to obtain additional information after the initial report was filed.During this call, the customer reported that the rash was also present on the inside of both elbows and may be eczema, a pre-existing skin condition.The customer also informed us that she has a latex allergy.She was advised by her co-worker (doctor) to confirm whether the product contained latex.The customer was informed that our pvc material does not contain latex.

• Brand Name: MDF
• Common Device Name: MDF ACOUSTICA DUAL HEAD STETHOSCOPE > ADULT > BLACKOUT/ALL BLACK/MDFBO
• Manufacturer (Section D): MDF INSTRUMENTS MEDIFRIEND INC; 1898 lai yin road, building 6,; jiu ting town, song jiang dis; shanghai, chn 20161 5; CH 201615
• Manufacturer (Section G): MDF INSTRUMENTS MEDIFRIEND INC; 1898 lai yin road, building 6,; jiu ting town, song jiang dis; shanghai, chn 20161 5; CH 201615
• Manufacturer Contact: davy zhang ; 1898 lai yin road, building 6,; jiu ting town, song jiang dis; shanghai, chn 20161-5 ; CH 201615
• MDR Report Key: 23282947
• Report Number: 3015989011-2025-00010
• Device Sequence Number: 18333390
• Product Code: LDE
• UDI-Device Identifier: 06940211618769
• UDI-Public: 6940211618769
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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
• Device Model Number: MDF747XPBO
• Device Catalogue Number: MDF747XPBO
• Device Lot Number: BF1008232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female