InHealth Technologies; Blom-Singer BE 6055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813307013068), received between Dec 20, 2019 and Dec 20, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryDec 20, 2019Material Fragmentation; Material Fragmentation

  DURING A REVIEW OF THE MAUDE DATABASE ON 11/22/2019, TWO USER REPORTS WERE DISCOVERED CONCERNING A TOTAL OF 2 OF INHEALTH'S TRACHEOESOPHAGEAL PUNCTURE SETS. FREUDENBERG MEDICAL HAD NOT BEEN MADE AWARE OF THESE EVENTS PRIOR TO THE MAUDE REVIEW. BOTH REPORTS READ AS FOLLOWS: "AN (B)(6) MALE. DURING PROCEDURE A PIECE OF THE PLASTIC SHEATH BROKE OFF INSIDE THE PATIENT. PIECE WAS SUCCESSFULLY RETRIEVED AND REMOVED FROM THE PATIENT. A SECOND SHEATH WAS ATTEMPTED AND ALSO STARTED TO TEAR, BUT DID NOT BREAK OFF. SECOND SHEATH REMOVED. FDA SAFETY REPORT ID # (B)(4). " FREUDENBERG MEDICAL DOES NOT HAVE ANY CONTACT INFORMATION TO FACILITATE A FOLLOW-UP WITH THE REPORTER.

  Patient problems: Foreign Body In Patient

  MAUDE report 9501047 ↗