NA 390157Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 37613327072502), received between Dec 9, 2019 and Dec 9, 2019 — classified as 1 injury.

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

• InjuryDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED: ON (B)(6) 2019 THE SECOND, THIRD, AND FOURTH ENDING METATARSAL BONES OF LEFT FOOT WERE BROKEN. ON (B)(6) 2019 THE SURGEON PERFORMED SURGERY FOR THE PATIENT. THE KIRSCHNER WIRE WAS IMPLANTED DURING THE MEDICAL PROCEDURE. THE CEFODIZIME WAS INJECTED TO ANTI-INFLAMMATORY AFTER PROCEDURE. THE INCISION OF LEFT FOOT PLACED A DRAINAGE-TUBE. THE DRAINAGE-TUBE WAS REMOVED ONE DAY LATER. ON OCTOBER 28, 2019 THE PATIENT HAS FEVER AND INCISION HAS EXUDATE. THE BODY TEMPERATURE IS 39.1. THE FEVER STAYED HIGH FOR THREE DAYS. THE HIGHEST BODY TEMPERATURE IS 39.4. ON (B)(6) 2019 THE SURGEON FOUND THE PATIENT¿S LEFT FOOT RED AND SWOLLEN, INCISION FESTER. IT CAN¿T RULE OUT KIRSCHNER WIRE CAUSED INFECTION. ON (B)(6) THE KIRSCHNER WIRE WAS REMOVED FROM FOOT. DRUG THERAPY WAS ADDED TO LAI LI XIN INJECTION TO ANTI - INFLAMMATORY TREATMENT. ON THE MORNING OF (B)(6) 2019 THE PATIENT¿S FOOT RED AND SWOLLEN AND INCISION SITUATION HAVE CHANGED TO BETTER. ON (B)(6) 2019 THE RED AND SWOLLEN HAS DISAPPEARED, NO SECRETION. THE INCISION WAS SEWN UP FOR THE SECOND TIME. THIS CASE BROUGHT VERY BIG PAIN TO PATIENT. AFFECTED INCISION HEALING AND EXTEND PATIENT TREATMENT TIME.

  Patient problems: Unspecified Infection

  MAUDE report 9440891 ↗