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Wings P3036PSRecalls & reported problems

Cardinal Health, Inc. · Quilted Premium Strength Underpad,Extra Heavy · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521155299), received between Oct 1, 2019 and Oct 1, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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

Device problems

  • Off-Label Use1

Patient problems

  • Adult Respiratory Distress Syndrome1
  • Swelling1
  • Vomiting1

Recent adverse event reports

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

  • InjuryOct 1, 2019Off-Label Use; Off-Label Use

    THE CUSTOMER REPORTED THAT A PATIENT IN THE HOSPITAL ATE THE UNDERPAD. PER THE DOCTOR, THE PATIENT STATED THAT HE COULD NOT BREATHE AND THE PATIENT WAS VOMITING UP LITTLE PELLETS. ADDITIONAL INFORMATION PROVIDED ON 09-SEP-2019 STATED THE PATIENT¿S STOMACH SWELLED AFTER EATING THE PRODUCT. THE PATIENT IS DOING BETTER AFTER PROFUSE VOMITING OF THE SUBSTANCE BUT THE STOMACH SWELLING IS STILL VISIBLE. THE DOCTOR IS KEEPING THE PATIENT HYDRATED TO TRY TO REDUCE THE STOMACH SWELLING.

    Patient problems: Adult Respiratory Distress Syndrome; Swelling; Vomiting

    MAUDE report 9142196 ↗

Other BEDDING, DISPOSABLE, MEDICAL devices

All BEDDING, DISPOSABLE, MEDICAL devices →

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