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PICO 66002006Recalls & reported problems

Smith & Nephew Medical Limited · PICO 7 KIT 15X20CM · Class 2

All models of PICO (13)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05000223493967), received between Feb 2, 2021 and Feb 2, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (4 reports).

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

  • Pumping Stopped4

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 2, 2021Pumping Stopped; Pumping Stopped

    IT WAS REPORTED THAT DURING NPWT, THE PICO7 PUMP SHUTS DOWN/STOPS AND DOES NOT START AGAIN. IT IS A TUMMY TUCK WITH A FLAT SURFACE THUS NO LEAKAGE. TREATMENT WAS COMPLETED WITH A NEW DEVICE WITH NO DELAY. NO PATIENT HARM REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11270747 ↗
  • MalfunctionFeb 2, 2021Pumping Stopped; Pumping Stopped

    IT WAS REPORTED THAT DURING NPWT, THE PICO7 PUMP SHUTS DOWN/STOPS AND DOES NOT START AGAIN. IT IS A TUMMY TUCK WITH A FLAT SURFACE THUS NO LEAKAGE. TREATMENT WAS COMPLETED WITH A NEW DEVICE WITH NO DELAY. NO PATIENT HARM REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11270728 ↗
  • MalfunctionFeb 2, 2021Pumping Stopped; Pumping Stopped

    IT WAS REPORTED THAT DURING NPWT, THE PICO7 PUMP SHUTS DOWN/STOPS AND DOES NOT START AGAIN. IT IS A TUMMY TUCK WITH A FLAT SURFACE THUS NO LEAKAGE. TREATMENT WAS COMPLETED WITH A NEW DEVICE WITH NO DELAY. NO PATIENT HARM REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11270690 ↗
  • MalfunctionFeb 2, 2021Pumping Stopped; Pumping Stopped

    IT WAS REPORTED THAT DURING NPWT, THE PICO7 PUMP SHUTS DOWN/STOPS AND DOES NOT START AGAIN. IT IS A TUMMY TUCK WITH A FLAT SURFACE THUS NO LEAKAGE. TREATMENT WAS COMPLETED WITH A NEW DEVICE WITH NO DELAY. NO PATIENT HARM REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11270656 ↗

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Sources and updates

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