C-Armor 5523 (UDI 00618125140152)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00618125140152), received between Oct 25, 2019 and Aug 26, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Device Emits Odor

  Patient problems: Headache

  MAUDE report 50457134 ↗
• MalfunctionNov 9, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  WE'RE AN ORTHOPEDIC SURGERY CENTER HERE IN (B)(6). WE'VE BEEN PURCHASING THE C-ARMOR DRAPE (5523) WITH MCKESSON. I JUST WANTED TO MAKE YOU GUYS AWARE THAT WE HAD A HOLE IN THE DRAPE THAT WE OPENED TODAY. LOT # 030764. I ASKED THE SURGICAL TECH THAT WAS IN THAT CASE AND SHE SAID IT HAS NEVER HAPPENED BEFORE AND SHE FEELS LIKE IT WAS MADE THAT WAY (NO CUT IN THE OUTER PACKAGING). WE HAVEN'T HAD ANOTHER ONE YET BUT I'LL BE SURE TO LET YOU KNOW IF WE HAVE ANOTHER. (EMAILS FROM CUSTOMER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15765372 ↗
• MalfunctionOct 25, 2019Material Integrity Problem; Material Integrity Problem

  DURING SURGERY, SURGEON AND STAFF NOTED BLACK FRAGMENTS FROM THE HOOK/LOOP PORTION OF THE DRAPE HAD FALLEN INTO THE WOUND DURING THE COURSE OF SURGERY. THE VISIBLE FRAGMENTS WERE REMOVED AND THE WOUND WAS IRRIGATED. ADVERSE REACTION IS UNKNOWN. PATIENT (B)(6), PT# (B)(6), ORIF, LEFT PATELLA. DURING A RETROSPECTIVE REVIEW WITH THE FDA HELP DESK, IT WAS DETERMINED THAT THIS COMPLAINT WAS INITIALLY SENT TO THE TEST REGION AND NOT THE FDA PRODUCTION REGION. THEREFORE, THIS REQUIRED A RESUBMISSION OF THIS MDR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9242464 ↗