Synergy® Surface P6880Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887761016538), received between Jul 2, 2025 and Jul 2, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Inflation 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. 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.

• InjuryJul 2, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED A CUSTOMER SUSTAINED A PRESSURE SORE WITH A SYNERGY MATTRESS. THE USER WAS UTILIZING THE SYNERGY MATTRESS AT HOME. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE USER FELT THE MATTRESS WAS ¿SUNKEN IN THE MIDDLE¿ AND ¿NO ERROR MESSAGES OR BEEPING¿ TRIGGED FROM THE BED. THE CUSTOMER WENT TO THE EMERGENCY ROOM WHERE SEVEN SUTURES WERE PLACED FOR A PRESSURE INJURY. REPORTEDLY, THE PRESSURE INJURY WAS ON THE SACRAL/GLUTEAL AREA AND ¿WAS PROBABLY LIKE A STAGE FIVE, IT WAS DOWN TO THE ARTERY.¿ THE PATIENT WAS ADMITTED INTO THE HOSPITAL WHERE THEY WERE TREATED WITH TRIAD, HYDROPHILIC WOUND DRESSING, AND CAUTERIZATION. THE PATIENT WAS DISCHARGED AFTER ¿TEN OR ELEVEN DAYS¿. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 22383810 ↗