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Provox FreeHands Support Medium
Atos Medical AB · Model 8022 · UDI-DI 07331791009280
10
510(k) clearances
827
Adverse events (21 deaths)
12
Recalls
144
Facilities
Description
Provox FreeHands Support provides support to the Provox adhesive when using a Provox hands-free speaking valve after total laryngectomy. The device is a single patient use device with a single use adhesive. The reusable Provox FreeHands Support is available in three different variants; ‘Flat’, ‘Medium’ and ‘Deep’. The three variants, as well as the possibility to adjust the metal ring and plastic parts, enable personal fit.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-23 | Hollister Incorporated | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration |
| 2024-12-23 | Hollister Incorporated | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration |
| 2024-12-23 | Hollister Incorporated | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration |
| 2024-12-23 | Hollister Incorporated | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration |
| 2024-11-18 | MEDLINE INDUSTRIES, LP - Northfield | Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip wh |
| 2024-11-18 | MEDLINE INDUSTRIES, LP - Northfield | Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip wh |
| 2024-11-18 | MEDLINE INDUSTRIES, LP - Northfield | Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip wh |
| 2024-11-18 | MEDLINE INDUSTRIES, LP - Northfield | Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip wh |
| 2017-03-24 | Dale Medical Products, Inc. | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face. |
| 2017-03-24 | Dale Medical Products, Inc. | ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.