Skip to content

Situate TSD-0875C-1Recalls & reported problems

Covidien LP · Tonsil Sponge - RF and X-ray Detectable Double Strung - Cotton Filled · Class 1

All models of Situate (29)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521701083), received between Oct 17, 2022 and Oct 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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

Device problems

  • Component Missing1
  • Detachment of Device or Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionOct 17, 2022Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, SPONGE, TONSIL RFD XRAY IN THIS PACK, WHICH HAS STRINGS ATTACHED TO REMOVE THEM FROM THE PATIENT'S THROAT, THE STRINGS WERE LIKE A RAT'S NEST AND WHEN THE SCRUB TRIED TO UNTANGLE AND PULL APART, THE STRINGS BECAME DETACHED AND THEREFORE UNUSABLE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15614596 ↗

Other GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices

All GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page