Peristeen 29127Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708932514934), received between Oct 18, 2019 and Jan 20, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2021Deflation Problem; Deflation Problem

  THIS CASE INVOLVES USE OF THE PERISTEEN TRANSANAL IRRIGATION SYSTEM ON A CHILD. AFTER USE OF THE DEVICE ON THE CHILD THE BALLOON ON THE CATHETER FAILED TO DEFLATE. THE BLUE TUBE WAS DISCONNECTED FROM THE DIAL; HOWEVER, THE BALLOON REMAINED INFLATED. IN ORDER TO DEFLATE THE BALLOON SUCCESSFULLY THE CLEAR PART OF THE BLUE TUBE HAD TO BE PHYSICALLY CUT BY THE USER. THE CHILD WAS NOT INJURED; HOWEVER, IT WAS STATED THAT THE CHILD WAS IN GREAT PAIN DUE TO THE INABILITY TO EVACUATE THE WATER AND STOOL PRIOR TO THE BALLOON DEFLATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 11204398 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, DURING THE INITIAL TRAINING FOR PERISTEEN, THE DAD INSERTED THE CATHETER INSIDE THE END USER'S VAGINA INSTEAD OF HER RECTUM AND THEN INFLATED THE BALLOON. THIS RESULTED IN BLEEDING THAT WAS HEAVY AND LASTED QUITE A LONG TIME. THE END USER WAS TAKEN TO THE HOSPITAL AND WAS EXAMINED. THE SURGEON PACKED THE VAGINA WITH DRESSING AND THE END USER WAS ADMITTED TO THE HOSPITAL WHERE SHE STAYED FOR TWO NIGHTS. THE WOUND WAS TREATED AS A LACERATION TO THE LINING OF THE VAGINAL AREA. THE END USER EXPERIENCED PAIN AS A RESULT OF THIS INCIDENT THAT LASTED PERHAPS 10 MINUTES. AFTER THAT, SHE WAS SHARING WITH THE NURSE HER ACTIVITIES FROM EARLIER IN THE DAY. DURING HER TIME IN THE HOSPITAL, THERE WERE NO COMPLICATIONS. THE WOUND "OOZED" AND THIS WAS CONSIDERED NORMAL AND EXPECTED BY THE SURGEON. SHE HAS HAD NO SPOTTING SINCE RETURNING HOME AND IS SAID TO BE "COMPLETELY OK" BY THE NURSE. THE FAMILY WILL BE RETURNING FOR TRAINING FOR THE PERISTEEN SYSTEM BECAUSE THEY BELIEVE IT WILL BE BENEFICIAL FOR THE END USER. MOM EXPLAINED THAT THE END USER IS STILL SPOTTING AND MAY EXPERIENCE SPOTTING FOR 2 WEEKS. THE END USER PASSED A CLOT OF BLOOD WHILE AT SCHOOL. TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9211644 ↗