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Phonak 063-0236-01Recalls & reported problems

Sonova AG · Phonak Virto B90-13 · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613275553169), received between May 4, 2023 and May 4, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • Laceration(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT ON (B)(6) 2023 PATIENT WAS FOUND IN A ROOM WITH THEIR LEFT EAR BLEEDING AND THE HEARING AID MELTED AND BLACKENED. THE DEVICE INVOLVED IS PHONAK VIRTO B90-13. PATIENT WAS TAKEN TO THE ER WHERE THEY RECEIVED 3 STITCHES IN THEIR CONCHA. ON (B)(6) 2023 PATIENT WAS SEEN BY THE HCP AND THE ENT CLINIC. ENT REMOVED THE STITCHES AND THE PATIENT'S EAR LOOKED WELL HEALED.THE PATIENT REFUSED TO RETURN THE DEVICE FOR ANALYSIS. INVESTIGATION IS ONGOING. THIS IS THE INITIAL REPORT, SUPPLEMENTAL REPORT WILL BE ISSUED WHEN MORE INFORMATION IS AVAILABLE.

    Patient problems: Laceration(s)

    MAUDE report 16868890 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.