Mui Scientific SR1BRecalls & reported problems

H & A Mui Enterprises Inc · Single-Use Anorectal Balloon Expulsion / Biofeedback Catheter · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00678467000774), received between Mar 8, 2024 and Mar 8, 2024 — classified as 1 malfunction.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Patient problems

Foreign Body In Patient1

Recent adverse event reports

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

MalfunctionMar 8, 2024
NURSE INSERTED BALLOON AND CATHETER INTO THE RECTUM AND INFLATED BALLOON. PATIENT WAS UNABLE TO DELIVER BALLOON INTO COMMODE. NURSE DEFLATED BALLOON AND REMOVE CATHETER. BALLOON WAS FOUND TO HAVE BEEN MISSING FROM THE CATHETER. UPON EVALUATION IT WAS NOTED THAT PATIENT HAD RETAINED BALLOON IN RECTUM. A FLEXIBLE SIGMOIDOSCOPY HAD TO BE PERFORMED TO REMOVE THE BALLOON.
Patient problems: Foreign Body In Patient
MAUDE report 18865185 ↗

Device details

UDI-DI	`00678467000774`
Brand	Mui Scientific
Model	SR1B
Company	H & A Mui Enterprises Inc
Product code	FFX · System, Gastrointestinal Motility (Electrical)
Class	Class 2
FDA submission	K823701
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 5, 2022

Device type (GMDN): Gastrointestinal motility manometric catheter, non-electronic

A non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and anal sphincter functions, typically in the evaluation of GI disorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence]. It functions via infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in/connected to a dedicated analysis system. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.