Sensica UO System SSPK1025Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741215643), received between Feb 2, 2022 and Jul 28, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE SENSICA RING WAS NOT ABLE TO BE USED ON THE SAME PATIENT WHEN TRANSFERRED TO A DIFFERENT DEVICE. CUSTOMER ALSO BROUGHT UP PAST INSTANCES OF RINGS FALLING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15124977 ↗
• MalfunctionJul 28, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SENSICA RING WAS NOT ABLE TO BE USED ON THE SAME PATIENT WHEN TRANSFERRED TO A DIFFERENT DEVICE. CUSTOMER ALSO BROUGHT UP PAST INSTANCES OF RINGS FALLING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15124800 ↗
• MalfunctionFeb 17, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE SENSICA DEVICE WAS NOT WORKING AND THE ONLY WAY THE USER COULD GET IT TO WORK WAS BY REPLACING THE RING. THERE WAS NO PATIENT HOOKED UP TO THE DEVICE AND THE CHARGE NURSE INDICATED THAT THEY COULD NOT RESTART THE UNIT. REPRESENTATIVE TRIED TO RESTART THE UNIT AND VERIFIED THAT AFTER PUSHING THE POWER BUTTON, THE GRAPHIC USER INTERFACE SCREEN CAME UP ASKING IF THEY WERE SURE TO RESTART AND THE YES OPTION COULD NOT BE PRESSED. ADDITIONALLY, OTHER BUTTONS ON THE MAIN GRAPHIC USER INTERFACE WERE UNRESPONSIVE. FURTHER VISUAL INSPECTION OF THE SCREEN INDICATED THAT THERE WAS A PERSISTENT PHANTOM TOUCH THAT SHOWED UP AS A CIRCLE ON THE SCREEN. THE PERSISTENT PHANTOM TOUCH WAS DETERMINED TO BE THE CAUSE FOR WHY THE SCREEN WAS UNRESPONSIVE. A RESTART OF THE UNIT WAS TRIGGERED BY ATTACHING AND DETACHING THE RING MULTIPLE TIMES. REPRESENTATIVE STATED THAT UPON RESTART, THE PHANTOM TOUCH DISAPPEARED, AND THE SCREEN WAS FULLY FUNCTIONAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13548666 ↗
• MalfunctionFeb 2, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE SENSICA DEVICE WAS ACTIVE, YET NOT FUNCTIONING CORRECTLY. NURSE BIOMED STATED THAT THERE WAS RING FAILURE AND HAD TO USE ANOTHER FROM A DIFFERENT ROOM. THEY WOULD EITHER NEED REPLACEMENT OR A DIAGNOSTIC APPROACH. ALSO, IT WAS REPORTED THAT THEY REGULARLY HAD TO REMOVE THE TUBE FROM THE TUBE HOLDER TO DRAIN THE SMALL STAGNANT PORTION OF URINE IN THE TUBE HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13428140 ↗