FDA Adverse Event
Malfunction
Summary report: N
ACOSOUND
MDR report key: 21351697
·
Received February 10, 2025
Report
- Report Number
- 3011350813-2025-00001
- Event Type
- Malfunction
- Date Received
- February 10, 2025
- Manufacturer
- HANGZHOU ACOSOUND TECHNOLOGY CO.,LTD.
- Product Code
- QUG
- UDI-DI
- 06973375880000
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
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.
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1657879 | ACOSOUND | HEARING AID | QUG | HANGZHOU ACOSOUND TECHNOLOGY CO.,LTD. | LW12-BTE-M | 110C | 06973375880000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |