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PICO 66002002Recalls & reported problems

Smith & Nephew Medical Limited · PICO 7 KIT 10X20CM · Class 2

All models of PICO (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 05000223493929), received between Nov 17, 2021 and Nov 17, 2021 — classified as 1 injury.

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 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER NPWT UTILIZING A PICO 7 10CM X 20CM, THE PATIENT HAD TO UNDERGO FURTHER AMPUTATION/OPERATION, AND IS BLAMING THE NURSE AND THE DEVICE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Insufficient Information

    MAUDE report 12831801 ↗

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Sources and updates

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