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AMD-RITMED 1501-ROLLRecalls & reported problems

AMD Medicom Inc · AMD-RITMED LAPAROTOMY SPONGE 4PLY 12 X 12 Inch · Class 1

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 20686864045216), received between Oct 20, 2020 and Oct 20, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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

  • Material Integrity Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionOct 20, 2020Material Integrity Problem; Material Integrity Problem

    A PRODUCT COMPLAINT WAS REPORTED TO AMD MEDICOM ON 28-AUG-2020 FOR AMD-RITMED LAPAROTOMY SPONGE ITEM CODE 1501-ROLL LOT# 81043-1. THE LAPAROTOMY SPONGE IS CLASSIFIED AS A CLASS 1 MEDICAL DEVICE UNDER FDA CODE GDY. THE FOLLOWING INFORMATION WAS INITIALLY REPORTED "LINT ON OVERHEAD TABLE COVER AND INSTRUMENTS. LINT ON LIVER DURING PROCEDURE" THE COMPLAINT RECEIVED BY AMD MEDICOM HAS BEEN LOGGED AS A PRODUCT QUALITY COMPLAINT UNDER (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10706696 ↗

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

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

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