MAUDE Adverse Event Report: HANGZHOU ACOSOUND TECHNOLOGY CO.,LTD. ACOSOUND; HEARING AID

Model Number	LW12-BTE-M
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the external review process, it was found that our product labels were not standardized.We traced back to the relevant reasons, re-learned the regulatory requirements, designed the labels according to the regulatory requirements, and began to use the new labels after approval.
Event or Problem Description
Our company mdsap certification audit findings:no evidence shows that the product label information without correct unique device identifier information and not complied udi requirements, without expiration date & place of business information, without correct manufacture information (information on label such as developed by acosound (manufacturer), customer blaids (not manufacturer) information on the label not correct marked.

• Brand Name: ACOSOUND
• Common Device Name: HEARING AID
• Manufacturer (Section D): HANGZHOU ACOSOUND TECHNOLOGY CO.,LTD.; room 401,no.2 building,no.1390; cangxing street,yuhang; hangzhou, zhejiang 31110 0; CH 311100
• Manufacturer (Section G): HANGZHOU ACOSOUND TECHNOLOGY CO.,LTD.; room 401,no.2 building,no.1390; cangxing street,yuhang; hangzhou, zhejiang 31110 0; CH 311100
• Manufacturer Contact: yang zhong ; room 401,no.2 building,no.1390 cangxing street,; yuhang; hangzhou, zhejiang 31110-0 ; CH 311100
• MDR Report Key: 21351697
• Report Number: 3011350813-2025-00001
• Device Sequence Number: 18411679
• Product Code: QUG
• UDI-Device Identifier: 06973375880000
• UDI-Public: 06973375880000
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Relabeling
• Type of Report: Initial

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: Other
• Device Model Number: LW12-BTE-M
• Device Catalogue Number: D485596
• Device Lot Number: 110C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown