Provox Life Standard Adhesive Oval 7461Recalls & reported problems
Atos Medical AB · Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy. · Class 1
Data updated Oct 18, 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 07331791014437), received between Jan 4, 2024 and Jan 4, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS GOING TO SEE THE DOCTOR ABOUT RADIOTHERAPY FOR HIS/HERS LUNG CANCER AND USED PROVOX LIFE LARYTUBE TOGETHER WITH PROVOX LIFE GO HEAT-MOISTURE EXCHANGER (HME) AND PROVOX LIFE STANDARD ADHESIVE. EVERYTHING WAS OK UNTIL THE PATIENT EXPERIENCED COUGHING AND HAD TO REMOVE THE LIFE LARYTUBE SINCE MUCUS GOT INTO IT. THE PATIENT HAD TO REMOVE THE HME BEFORE REMOVING LIFE LARYTUBE AND DECIDED TO PUT THE HME BACK (ATTACHING IT TO THE ADHESIVE) TO BE ABLE TO SPEAK. AT THE END OF THE DOCTOR'S APPOINTMENT, THE PATIENT PUSHED THE HME THROUGH THE HOLE OF THE ADHESIVE. THE HME ENDED UP BEING STUCK IN THE PATIENT'S AIRWAYS. THE PATIENT WAS ABLE TO SUCCESSFULLY REMOVE THE HME AND A SECTION OF THE ADHESIVE FROM THE AIRWAYS WITH BARE HANDS, BUT DESCRIBED IT TO BE UNDER STRESSFUL CIRCUMSTANCES. DESCRIPTION OF PROVOX LIFE LARYTUBE: PROVOX® LIFE LARYTUBE IS A TUBE MADE OF MEDICAL GRADE SILICONE RUBBER. IT IS DELIVERED SINGLE PACKED AND NON-STERILE. PROVOX® LIFE LARYTUBE PROVIDES ATTACHMENT FOR PROVOX® LIFE HMES AND PROVOX® LIFE SHOWER. STANDARD MODEL - MADE FOR USE WITH OR WITHOUT A VOICE PROSTHESIS. CAN BE ATTACHED WITH A PROVOX® TUBEHOLDER, PROVOX® LARYCLIP OR FREEVENT® NECKBAND. FENESTR
Patient problems: Foreign Body In Patient
MAUDE report 18442149 ↗
Other Tape And Bandage, Adhesive devices
- IV3000-1-HAND 10X12CM-CARTON OF 50 66024008Smith & Nephew Medical Limited · Tape And Bandage, Adhesive62 reports
- CURAD NON25600QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall2 reports
- IV3000-1-HAND 6X7CM-CARTON OF 100 66024007Smith & Nephew Medical Limited · Tape And Bandage, Adhesive52 reports
- 3M™ 1500U3m Company · Tape and bandage, adhesive1 recall1 report
- CURAD NON25650QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall1 report
- CURAD NON256133QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall0 reports
- CURAD NON25660QSMedline Industries, Inc. · Tape and bandage, adhesive1 recall0 reports
- Seer Home SM-01-9005Seer Medical Holdings Limited · Tape And Bandage, Adhesive1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page