MEROCEL® 470404Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20681490115050), received between Feb 10, 2017 and Nov 20, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2020Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT HAD COUGHED AND ONE OF THE DRESSINGS CAME OUT OF HIS MOUTH AND THE OTHER ONE THEY COULDN'T FIND- SUSPECTED SWALLOWED. THE HOSPITAL DID A CHEST X-RAY AND COULD NOT SEE THE DRESSING. PATIENT IS ABLE TO TALK AND SWALLOW SO DRESSING IS NOT IN THE ESOPHAGUS. THE SURGEON WAS INFORMED PRODUCT WAS NOT HARMFUL IF SWALLOWED. SURGEON WAS SENT THE PRODUCT INFORMATION DOCUMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 10874012 ↗
• MalfunctionFeb 10, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION RECEIVED: THE DOCTOR CONFIRMED THAT ¿SHE HAD THE PACKING ANCHORED. SHE TAPED IT ONTO THE PATIENT¿S CHEEK.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 6323339 ↗