Baha 5 Power, Brown 95473Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09321502034616), received between May 19, 2020 and Dec 2, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED INFLAMMATION AT THE MAGNET SITE THAT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS. THE IMPLANT REMAINS IN-SITU.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 15902683 ↗
• InjuryDec 2, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED INFLAMMATION AT THE MAGNET SITE THAT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS. THE IMPLANT REMAINS IN-SITU.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 15902533 ↗
• InjuryMay 19, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INFECTIONS UNDER THE PROCESSOR.

  Patient problems: Unspecified Infection

  MAUDE report 10073487 ↗
• InjuryMay 19, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INFECTIONS UNDER THE PROCESSOR.

  Patient problems: Unspecified Infection

  MAUDE report 10073485 ↗