SOLIDEA 065234Recalls & reported problems

Calzificio Pinelli Srl · SOCKS FOR YOU FREEDOM JAZZ, SIZE M, BORDEAUX, ANATOMIC COMPRESSION UNISEX LOW CUT SOCK MADE OF PRECIOUS BAMBOO YARN · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08300496065234), received between May 23, 2025 and May 23, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Energy Output 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Energy Output Problem1
Self-Activation or Keying1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionMay 23, 2025Energy Output Problem; Self-Activation or Keying; Energy Output Problem; Self-Activation or Keying
ACCORDING TO THE REPORTER PRIOR TO USE, THE FOOTSWITCH COAGULATION WAS PRESSED BUT THE CUT FUNCTION WAS WORKING AND VICE VERSA. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22079534 ↗

Device details

UDI-DI	`08300496065234`
Brand	SOLIDEA
Model	065234
Catalog no.	0591A4
Company	Calzificio Pinelli Srl
Product code	FQL · Stocking, Medical Support (For General Medical Purposes)
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 26, 2021

Device type (GMDN): Compression/pressure sock/stocking, reusable

A garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a reusable device.

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