QuikClot 4030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841495140303), received between Jun 8, 2021 and Jun 8, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Entrapment of Device” (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

Recent adverse event reports

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

• InjuryJun 8, 2021Entrapment of Device

  Z-MEDICA, LLC RECEIVED A MEDWATCH FORM FROM THE HOSPITAL ON 5/21/2021. THE REPORT ALLEGED THE THERE WERE RETAINED LAPAROTOMY PADS. THE PATIENT HAD EXPLORATORY LAPAROSCOPY FOR A SUSPECTED PERFORATED DESCENDING COLON. THE PATIENT HAD A VAST AMOUNT OF CANCEROUS TISSUE THAT NEED TO BE REMOVED. DURING THE SURGERY THE PATIENT HAD TOTAL ABDOMINAL COLECTOMY, OMENECTOMY, APPENDECTOMY, BSO, HYSTERECTOMY, AND AN END ILEOSTOMY CREATED ON (B)(6) 2021. QUIKCLOT CONTROL+ DRESSINGS WERE PLACED DEEP IN THE PELVIS TO HELP WITH HEMOSTASIS. THE HOSPITAL REPORT THAT ALL COUNTS WERE CORRECT AT THE END OF THE CASE. THE PATIENT HAD A DELAYED RETURN OF BOWEL FUNCTION AND A CT WAS PERFORMED ON (B)(6) 2021. WHICH SHOWED RETAINED LAP PADS. THE PATIENT WAS TAKEN INTO SURGERY ON (B)(6) 2021 FOR REMOVAL OF THE FOREIGN OBJECTS. ONE LAP SPONGE WAS FOUND IN THE PELVIS AND THE OTHER IN THE RIGHT PARACOLIC GUTTER. THE PATIENT HAD AN UNEVENTFUL SURGERY AND WAS DISCHARGED ON (B)(6) 2021. THE CUSTOMER "OPINED THAT THE X-RAY DETECTABLE ON THE LABEL WAS NOT PROMINENT AND STAFF MAY THINK SPONGES DO NOT NEED TO BE COUNTED".

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11957318 ↗