PICO 66022012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05000223492373), received between Feb 26, 2026 and Feb 26, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (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.

• InjuryFeb 26, 2026Leak/Splash; Biocompatibility

  IT WAS REPORTED THAT, DURING NPWT, PATIENT EXPERIENCED ITCHING AND BLISTERS USING THE PICO 7 SINGLE DRESSING 10CM X 20CM. THIS ADVERSE EVENT WAS ADDRESSED WITH ROUND-THE-CLOCK MAXIMUM DOSES OF IV AND ORAL ANTIHISTAMINES (FOR THE ALLERGIC REACTION), PLUS PAIN MEDICATION (INCLUDING NORCO) WHICH ALLOWED TO PATIENT TO TOLERATE IT AT THE TIME. PATIENT USED A SECOND PICO, THREAE-DAYS POST HOSPITAL DISCHARGE. SHE HOPED TO CONTROL ANY RECURRENCE AT HOME USING ORAL ANTIHISTAMINES (ATARAX, ZYRTEC, AND BENADRYL) AND TOPICAL BENADRYL CREAM. UPON ARRIVAL TO HOME, PATIENT TOOK ATARAX WITH MINIMAL RELIEF AND THEN, 25 MG OF BENADRYL WHICH LED TO COMPLETE SEDATION. ALTHOUGH, PATIENT WOKE UP DUE TO CONTINUED PUMP CYCLING; THE SEAL BROKE FROM RAISED HIVES/WELTS AND THE PUMP INDICATOR CHANGED TO ORANGE (LEAK DETECTED) AS CONSEQUENCE SHE TOOK ADDITIONAL 50MG OF BENADRYL. AT THIS STAGE, PATIENT WAS EXPERIENCING INSANE, UNBEARABLE ITCHING; AND THE SKIN UNDER THE ADHESIVE WAS INFLAMED AND BLISTERED. ATARAX PROVIDED NO RELIEF AFTER 45 MINUTES. AFTER THIS, HUSBAND'S PATIENT REMOVED THE DRESSING AND APPLIED BENADRYL CREAM LIBERALLY WITH NO SIGNIFICANT RELIEF. THEN, THEY ATTEMPTED TO SALVAGE THE DRESSING BY A

  Patient problems: Blister; Itching Sensation; Rash; Skin Inflammation/ Irritation; Urticaria

  MAUDE report 24455356 ↗