Peristeen 29129Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05708932544528), received between Feb 15, 2017 and Feb 18, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, COLOPLAST WAS NOTIFIED ABOUT AN INCIDENT INVOLVING PERISTEEN TRANSANAL IRRIGATION SYSTEM, RESULTING IN BOWEL PERFORATION. NO ADDITIONAL DETAILS ARE AVAILABLE TO DATE.

  Patient problems: Abdominal Distention; Abscess; Bowel Perforation; Sepsis

  MAUDE report 13559156 ↗
• InjuryNov 16, 2021Device Handling Problem; Device Handling Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS CASE CONCERNS A (B)(6) FEMALE PATIENT WITH SCI AT T2 AND RELATED NEUROGENIC BOWEL DYSFUNCTION DUE TO A MOTOR VEHICLE ACCIDENT IN 2016. DUE TO SYMPTOMS RELATED TO NEUROGENIC BOWEL DYSFUNCTION (INCONTINENCE, TIME CONSUMING BOWEL MANAGEMENT, INCOMPLETE EVACUATION), DAILY TAI WITH 350ML WATER WAS INITIATED ON (B)(6) 2021 USING THE SMALL CATHETER WITH 2 PUMPS OF THE BALLOON. TRAINING WAS A 2-HOUR TRAINING SESSION AT THE PHYSICIAN¿S OFFICE WITH A 1-HOUR DEMONSTRATION FOLLOWED BY THE MOTHER OF THE PATIENT PERFORMING THE IRRIGATION. ON (B)(6) 2021 AT THE SECOND ATTEMPT AT HOME AFTER THE INITIAL TRAINING (FIRST IRRIGATION WAS SUCCESSFUL) THE MOTHER ACCIDENTLY INSERTED THE CATHETER INTO THE VAGINA INSTEAD OF HER RECTUM WHILE THE PATIENT WAS SEATED ON A SHOWER CHAIR AND THEN INFLATED THE BALLOON WITH 2 PUMPS. THE PATIENT HAD INSTANT DISCOMFORT/PAIN AND IMMEDIATE VAGINAL BLEEDING. THE PATIENT WAS ADMITTED TO EMERGENCY 1 HOUR AFTER THE INCIDENT WHERE A CT SCAN OF THE ABDOMEN AND PELVIS CONFIRMED A VAGINAL TRAUMATIC LACERATION. THE CERVIX AND CERVICAL OS WERE INTACT BUT LATERAL TO THE CERVIX AT THE LEVEL OF THE RIGHT VAGINAL WELL "EXTERNING" ¾ OF THE

  Patient problems: Internal Organ Perforation

  MAUDE report 12820318 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS INVOLVES A FEMALE PATIENT USING THE PERISTEEN TRANSANAL IRRIGATION SYSTEM. THE PATIENT HAS BEEN EXPERIENCING LIGHT BLEEDING ON AND OFF WHILE USING PERISTEEN SINCE EARLY JANUARY. THE PATIENT COMPLAINED OF CRAMPING AND DIFFICULTY WITH REMOVAL OF THE STOOL. THIS HAS HAPPENED SEVERAL TIMES. THE BLEEDING BECAME INCREASINGLY WORSE UNTIL THE 2ND FEBRUARY WHEN SHE EXPERIENCED HEAVY BLEEDING WITH A RELEASE OF MUCUS. THE PATIENT HAS NOT USED PERISTEEN SINCE BUT CONTINUED HAVING HEAVY BLEEDING AND CRAMPING ON THE 11TH FEBRUARY. ON THE 12TH AND 13TH OF FEBRUARY LIGHT BLEEDING WAS EXPERIENCED AND ON THE 14TH FEBRUARY, LIGHT STAINING WAS NOTED. THERE HAS BEEN NO REPORT OF TREATMENT FOR THE BLEEDING AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Cramps; Gastrointestinal Hemorrhage

  MAUDE report 11463340 ↗
• InjuryApr 19, 2017Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, DAUGHTER STARTED USING PAI AROUND FRIDAY (B)(6). BY (B)(6) SHE WENT TO HER SCHOOL NURSE AND REPORTED RECTAL BLEEDING AND PAIN. SHE DID NOT INFORM HER MOM UNTIL (B)(6). HER MOM TOOK HER IMMEDIATELY TO THE ER AND DOCTORS FOUND NO SIGNS OF BOWEL PERFORATION, THEY INSTRUCTED MOM TO GO HOME AND DOUBLE LAXATIVE INTAKE. END USER IS STILL SUFFERING FROM LIGHT BLEEDING AND MOM INFORMED ME THAT HER DAUGHTER HAS HAD A HISTORY OF HEMORRHOIDS AND PERHAPS THE HEMORRHOID ISSUE IS FAR MORE SERIOUS THAN THEY WERE AWARE OF. THEY HAVE APPOINTMENTS SCHEDULED TO VISIT SPECIALIST TO DOUBLE CHECK THE FEEDBACK FROM THE ER. ADDITIONAL INFORMATION RECEIVED: GI SPECIALIST DISCOVERED THAT END USER HAS HAD A FISSURE & HEMORRHOIDS DURING HER USE OF PERISTEEN. MOM WAS NOT CLEAR ON THE GRADE OR DEGREE OF THE HEMORRHOIDS, THEY WERE INSTRUCTED TO STOP USE OF PERISTEEN WHILE THEY TREAT HER CURRENT SYMPTOMS. THE SPECIALIST IS CONSIDERING BANDING THE HEMORRHOIDS. THE END USER IS REALLY HOPING TO CONTINUE USE OF PERISTEEN, BUT THE HCP'S WILL SEE IF THAT WILL BE AN OPTION BASED ON HOW WELL SHE RECOVERS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Skin Tears

  MAUDE report 6503009 ↗
• InjuryFeb 15, 2017Migration or Expulsion of Device

  ACCORDING TO THE AVAILABLE INFORMATION, (B)(6) YEAR OLD PATIENT'S MOTHER SAID ALL HAS BEEN GOING WELL WHEN SHE NOTICED THAT SOME OF HIS "INSIDES WERE ON THE OUTSIDE." SHE SAID THERE WAS ABOUT 1 INCH EXTERNALLY. TOLD HER TO NOT USE THE SYSTEM AT ALL UNTIL SHE CAN TALK TO THE PRESCRIBING DOCTOR ABOUT WHAT IS GOING ON. SHE ALSO SAID THAT IS BOWELS ARE SO LOOSE NEAR HIS RECTUM THAT IF HE BEARS DOWN AT ALL HE CAN EXPEL THE CATHETER WITH THE BALLOON INFLATED - CURRENTLY USING PEDIATRIC CATHS. MOTHER IS CONCERNED ABOUT IT AND THAT THE CLINIC TOLD HER JUST TO GENTLY PUSH THE INTESTINES BACK IN, WHICH SHE HAS BEEN DOING BUT FEELS LIKE MORE IS COMING OUT THAN BEFORE AND THERE ARE TIMES SHE CAN'T GET THEM BACK IN. THEY HAD AN APPOINTMENT WITH A SURGEON LAST WEEK, AND THEY ARE PLANNING ON HAVING THE END USER SCOPED - SIMILAR TO A COLONOSCOPY - TO LOOK FOR ANY ULCERATIONS WHICH CAN BE CAUSE BY HAVING THE INTESTINES COMING OUT AND BEING PUSHED BACK IN REPEATEDLY. HE WILL THEN HAVE SURGERY TO STITCH THE INTESTINES IN PLACE. PER MOTHER, THE SURGEON WASN'T SURE IF PERISTEEN WAS A CONTRIBUTING FACTOR OR JUST COINCIDENCE.

  Patient problems: No Code Available; Prolapse

  MAUDE report 6331712 ↗