FLEXI-SEAL 421630Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00768455143016), received between Jul 27, 2020 and Feb 3, 2026 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (14 reports).

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026

  RN ATTEMPTED TO FLUSH WATER THROUGH RECTAL TUBE IN PREPARATION FOR MEDICATION ADMINISTRATION WHEN NOTICED BULDGING OF THE RECTAL TUBE IN VARIOUS SPOTS WITH CONCERN FOR OUTPOUCHING OF FLUID AND POTENTIAL RUPTURE. RECTAL TUBE REMOVED AND NEW RECTAL TUBE PLACED. NO KNOWN INJURY AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245993 ↗
• MalfunctionMay 17, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED AN INTENSIVE CARE PATIENT EXHIBITED MULTI-ORGAN FAILURE, AND CHRONIC DIARRHEA, WHICH JUSTIFIED FLEXI-SEAL BASED ON NURSING BENEFIT. THE PATIENT HAD A FLEXI-SEAL PROTECT IN PLACE FOR THREE WEEKS. "BLEEDING FROM THE RECTUM WAS OBSERVED, AND A RECTOSCOPY SHOWED CIRCUMFERENTIAL NECROSIS IN THE DISTAL RECTUM. THE EXAMINATION ALSO FOUND THAT THE PRODUCT WAS FILLED WITH MORE THAN 100 ML OF WATER WHEN IT SHOULD ONLY BE FILLED WITH LESS THAN OR EQUAL TO 45 ML. THE PATIENT WAS HOSPITALIZED FOR ANOTHER MONTH AND WAS THEN DISCHARGED. HOWEVER, THE PATIENT WAS READMITTED SHORTLY AFTER WITH ABDOMINAL PAIN, WHICH IS CONFIRMED TO BE DUE TO OBLITERATING SWELLING IN THE DISTAL BOWEL WHERE THE PREVIOUS INJURY WAS NOTED AND IS INTERPRETED AS A DIRECT EFFECT OF THIS. THE PATIENT GOT OPERATED AND GOT A RELIEVING SIGMOID OSTOMY." PER THE INFORMATION PROVIDED, THE PROBABLE CAUSE IS "DUE TO A MISTAKE IN USE WHERE THE FLUSHING CHANNEL WAS CONFUSED WITH THE CUFF, WHEREBY THE CUFF BALLOON WAS ENLARGED AND COULD CAUSE PRESSURE DAMAGE TO THE INTESTINE. IT IS QUITE POSSIBLE TO CONFUSE THESE AS THE SAME SYRINGE CAN BE USED WITH LUER COUPLING. THE MARKING IS PRESENT BUT NOT VERY CLEAR."

  Patient problems: Necrosis; Pain

  MAUDE report 19339686 ↗
• InjuryJun 22, 2023Off-Label Use; Off-Label Use

  IT WAS REPORTED "NO PR EXAM PRIOR TO INSERTION OF FMS; PATIENT WAS RESTLESS SO THE DEVICE WAS REMOVED AFTER ONLY 7 HOURS IN SITU. AFTER 21 DAYS POST REMOVAL, THE PATIENT WAS NOTED TO BE ADMITTED WITH CIRCUMFERENTIAL RECTAL NECROSIS, SUBSEQUENTLY REQUIRING TO HAVE A PERMANENT COLOSTOMY."

  Patient problems: Necrosis

  MAUDE report 17181572 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD A FULL THICKNESS PRESSURE INJURY WHEN USING THE FECAL MANAGEMENT DEVICE (FMS). FMS WAS IN PLACE (B)(6) 2022. IT WAS UNKNOWN IF A RECTAL EXAM WAS DONE PRIOR TO PLACEMENT AND UNKNOWN HOW MUCH FLUID WAS INSTILLED IN THE DEVICE. MEDICAL TREATMENT WAS PROVIDED HOWEVER TYPE OF MEDICAL TREATMENT WAS NOT PROVIDED. THE FMS DEVICE WAS DISCONTINUED. PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Tissue Breakdown

  MAUDE report 16910821 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #13 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15886079 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #12 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15886036 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #14 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15886035 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #7 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885991 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #11 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885988 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #6 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885986 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #5 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885983 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #4 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885981 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #10 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885975 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS INITIALLY REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. STATES "HIS TUBE WAS LEAKING SO BADLY". THE CONSUMER DID HAVE EXISTING SKIN BREAKDOWN IN THE SACRAL AREA BUT NOT THE RECTAL AREA. THE CONSUMER'S FECAL OUTPUT IS BEING MONITORED EVERY 1-2 HOURS AND AVERAGES 100-500 ML OF WATERY, LOOSE STOOL. SKIN BARRIER CREAMS ARE NOT USED AS THE FACILITY USES CASP (3M CAVILON¿ ADVANCED SKIN PROTECTANT) ON MONDAY, WEDNESDAY AND FRIDAY. HOWEVER, IT WAS STATED "THE STAFF IS NOT CONSISTENT IN APPLYING THE CASP", AND THEY "DO NOT ROUTINELY IRRIGATE THE FLEXISEAL PROTECT." PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM NURSING HOME. THE "FLEXISEAL PROTECT WAS INSERTED ON (B)(6) DUE TO LOOSE, LIQUID STOOLS AND IT WAS DOCUMENTED THAT THE AMOUNT FLUID INSTILLED WAS 45 ML." IT WAS DOCUMENTED "INSERTED PER PROTOCOL BUT NO PRIOR DOCUMENTATION OF RECTAL TONE NOTED. THE PRESSURE INJURY WAS FIRST NOTED ON (B)(6). THE PRESSURE INJURY WAS STAGED AS A DEEP TISSUE INJURY WITH PURPLE/RED DISCOLORATION TO THE PERINEAL AREA MEASURING 3 X 1 CM. THE INJURY HAS NOT EVOLVED AT THIS TIME AND CONTINUES TO BE STAGED AS A DEEP T

  Patient problems: Tissue Breakdown

  MAUDE report 15885969 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #8 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885968 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #9 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885966 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #2 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885961 ↗
• InjuryNov 30, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED "THAT A PATIENT USING FLEXISEAL PROTECT FMS DEVELOPED A PRESSURE INJURY TO THE PERINEUM. IT WAS ALSO STATED THERE "LEAKAGE IS AROUND THE RECTAL TUBE" AND THEY "ARE SEEING AN INCREASE IN HAPIS AROUND RECTAL TUBES". STAFF IS NOT CONSISTENT WITH USE OF CASP MWF AS THEIR SKIN PROTECTANT. THEY DO NOT IRRIGATE DAILY. PER ADDITIONAL INFORMATION RECEIVED, CASP WAS CLARIFIED TO BE "3M CAVILON¿ ADVANCED SKIN PROTECTANT ". A TOTAL OF 14 PATIENTS WERE IDENTIFIED TO HAVE PRESSURE INJURY TO THE PERINEUM, HOWEVER NO INFORMATION WAS PROVIDED FOR 13 OF THE PATIENTS ALTHOUGH INFORMATION HAS BEEN REQUESTED. THIS EMDR IS COVERING PATIENT #3 OF 14 PATIENTS REPORTED BY THIS REPORTER. THE REMAINING PATIENTS ARE COVERED IN SUBSEQUENT EMDRS.

  Patient problems: Tissue Breakdown

  MAUDE report 15885960 ↗
• InjuryJan 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  A MEDWATCH FORM WAS RECEIVED ((B)(4)). IT WAS REPORTED THAT A MALE PATIENT WITH HISTORY OF SEVERE ALCOHOL ABUSE DISORDER, LIVER CIRRHOSIS, HISTORY OF MALLORY WISE TEARS WAS ADMITTED WITH SEVERE UPPER GI BLEED REQUIRING BLOOD TRANSFUSION AND INTERVENTION TO STOP BLEEDING. THE PATIENT WAS HAVING WHAT WAS REPORTED AS "PROFUSE PERSISTENT LIQUID STOOLS" SO FECAL MANAGEMENT SYSTEM PLACED. THE DEVICE WAS IN PLACE FOR TEN DAYS WHEN "LARGE AMOUNT OF BRIGHT RED BLOOD" WAS NOTED IN THE DEVICE. PER THE REPORT IT WAS INITIALLY THOUGHT TO BE FROM UPPER GASTROINTESTINAL BLEED. ON DAY 11, A COLONOSCOPY WAS PERFORMED AND THE FINDINGS WERE "CIRCULAR ULCERATION LIKELY FROM FECAL MANAGEMENT SYSTEM BULB FOUND TO BE SOURCE OF BLEEDING, CAUTERIZED AND BIOPSIED AREA". HOWEVER, OVERNIGHT THE PATIENT BECAME "UNRESPONSIVE WITH BRIGHT RED BLOOD AND CLOTS FROM RECTUM". PER THE REPORTED, THE PATIENT "CODED AND RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED, BUT PATIENT REMAINED UNSTABLE". THE PATIENT RECEIVED "MASSIVE TRANSFUSION AND SECOND SURGERY WITH EPI INJECTION AND CLIPS X3-TRIED AND UNSUCCESSFUL". THE PATIENT WAS THEN "TAKEN FOR RECTAL ARTERY EMBOLIZATION". THE PATIENT WAS MADE COMFORT MEASURES AND EXPIR

  Patient problems: Shock; Tissue Breakdown

  MAUDE report 13287533 ↗
• InjuryJul 27, 2020Adverse Event Without Identified Device or Use Problem

  ELDERLY MAN WAS ADMITTED WITH VENTRICULAR FIBRILLATION/VENTRICULAR FIBRILLATION ARREST RELATED TO INFEROLATERAL ST-ELEVATION MYOCARDIAL INFARCTION DUE TO CATHERIZATION FOR DRUG ELUTING STENT IN RIGHT CORONARY ARTERY. DURING PROLONGED HOSPITAL COURSE DEVELOPED LARGE AMOUNTS OF LIQUID DIARRHEA. IN ORDER TO PROTECT SKIN, A FECAL MANAGEMENT SYSTEM (RECTAL TUBE) WAS EMPLOYED TO CONTROL AND CONTAIN THE STOOL. THE TUBE WAS PLACED ONE WEEK LATER. DURING THE USE OF THE FECAL MANAGEMENT SYSTEM, THE BALLOON WAS REGULARLY CHECKED, DEFLATED AND WAS INFLATED WITH 30-40 ML (BELOW THE MANUFACTURER'S MAXIMUM 45 ML). 3 WEEKS LATER, THE PATIENT DEVELOPED BRIGHT RED BLOOD PER RECTUM WITH HEMODYNAMIC DECOMPENSATION. THE PATIENT UNDERWENT LOWER ENDOSCOPY WHICH IDENTIFIED AN ULCER IN THE DISTAL RECTUM CONSISTENT WITH PRESSURE NECROSIS THAT HAD ERODED INTO AN ARTERY WHICH WAS SUCCESSFULLY CLIPPED.

  Patient problems: Diarrhea; Necrosis; Ulcer; Ventricular Fibrillation

  MAUDE report 10325697 ↗