Cook G53740Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002537408), received between Nov 29, 2018 and Sep 22, 2026 — classified as 2 injuries.

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 18, 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.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient with stress urinary incontinence received the blinded investigational study drug at a dose of 150 million cells via intramuscular route. Later, the unblind visit was performed where the subject's treatment allocation was confirmed as placebo, post which the patient opted to receive AMDC-USR (Autologous Muscle Derived Cells) injection using Cook MYOSITE SIMULTANEOUS INJECTION DEVICE. The needle functioned normally before the procedure, and no device issues were observed. A field product specialist present during the procedure did not note any abnormalities. Shortly after receiving the AMDC-USR injection the patient developed Dehydration, Chest pain, Nausea and Diaphoresis (excessive sweating).These events occurred within minutes of the injection procedure resulting in overnight hospitalization. A cardiac evaluation did not indicate a heart-related event. The patient was treated with IV normal saline (0.9%) and Zofran (ondansetron). The symptoms resolved, and the subject was discharged from the hospital the following day.No other adverse effects were reported for this incident.

  Patient problems: Chest Pain; Dehydration; Diaphoresis; Nausea

  MAUDE report 50857638 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem

  THIS ADVERSE EVENT OCCURRED AS PART OF A CLINICAL TRIAL (PROTOCOL13-003-05) AND THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. IT WAS REPORTED THAT APPROXIMATELY 5 MINUTES AFTER USE OF THE MYOSITE SIMULTANEOUS INJECTION DEVICE FOR INJECTION OF AUTOLOGOUS MUSCLE DERIVED CELLS (AMDC) FOR STRESS URINARY INCONTINENCE THE PATIENT DEVELOPED AN ALLERGIC REACTION OF TOTAL BODY FLUSHING AND THROAT CONSTRICTION. THE PATIENT WAS TREATED WITH BENADRYL, EPINEPHRINE, DECADRON, FAMOTIDINE, AND PREDNISONE AND TAKEN TO THE EMERGENCY ROOM FOR MONITORING. THE REACTION RESOLVED THE FOLLOWING DAY, AND SHE BEGAN RECEIVING ONGOING BENADRYL AND METHYLPREDNISOLONE. THE PATIENT HAD RECEIVED A BIOPSY 70 DAYS PRIOR TO THIS INJECTION, AT WHICH POINT THEY ALSO BEGAN RECEIVING CIPRO, WHICH CONTINUED UNTIL THE DAY AFTER THE MYOSITE INJECTION. ON THE DAY OF THE PROCEDURE SHE RECEIVED LIDOCAINE 2%. URETHRAL DILATATION WAS NOT REQUIRED. THERE WERE A TOTAL OF NINE INJECTIONS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8117289 ↗