NOVAPLUS V11500-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10630140021831), received between Oct 2, 2019 and Oct 2, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2019Burst Container or Vessel; Fluid/Blood Leak

  BASED ON INFORMATION RECEIVED FROM THE CUSTOMER THE PATIENT REPORTEDLY THOUGHT THE ICE PACK BURST, THE PATIENT STATED SHE RAN INTO THE SHOWER AND RINSED PERINEAL AREA WITH WATER. NURSE LIFTED PERINEAL PAD FROM GROUND AND FOUND THAT SOLUTION WAS LEAKING IN A STEADY STREAM FROM TEAR IN PAD. NURSE WAS WEARING GLOVES AND NOTED THAT THE FLUID WAS EXTREMELY COLD. SHE IMMEDIATELY ASSESSED PATIENT¿S PERINEUM AND NOTED NEW BLISTERING ON PRE-EXISTING HEMORRHOIDS. BLISTER WAS SMALL, ABOUT 5 MM IN DIAMETER. PATIENT REPORTED RELIEF TO BASELINE AFTER RINSING IN THE SHOWER; HOWEVER, REMAINED UNCOMFORTABLE. HER PERINEUM WAS ALREADY UNCOMFORTABLE FROM TISSUE TRAUMA FROM RECENT CHILDBIRTH, SO THIS IS DIFFICULT TO ATTRIBUTE TO THE BLISTER ALONE.

  Patient problems: Discomfort; Tissue Damage

  MAUDE report 9147879 ↗