3M™ Tegaderm™ 1626WRecalls & reported problems
3m Company · 3M(TM) Tegaderm(TM) Transparent Film Dressing Frame Style 1626W · Class 1
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 04001895928765), received between Aug 28, 2019 and Aug 28, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Patient Device Interaction 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Erythema1
- Rash1
- Skin Irritation1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
A HEMATOLOGY BLOOD TRANSFUSION HOSPITAL IN (B)(6) REPORTED SIX PEDIATRIC PATIENTS (ALL AGES AND GENDERS NOT PROVIDED) WITH A PORT-A-CATH ALLEGEDLY EXPERIENCED SKIN IRRITATION AND POSSIBLE INFECTION. THE HOSPITAL REPORTED 1626W 3M¿ TEGADERM¿ DRESSINGS WERE APPLIED TO PROTECT THE PORT-A-CATH ON EACH PATIENT. CLABSI WAS ALLEGED FOR TWO OF THE CHILDREN, WHERE A PHYSICIAN REPLACED THE PORTS. NO FURTHER DETAILS WERE PROVIDED ON THESE TWO INCIDENTS. OPEN PACKAGING OF THE TEGADERM DRESSING WAS ALSO REPORTED. THE HOSPITAL PROVIDED SPECIFIC DETAILS ON THREE PATIENT INCIDENTS; A MALE PEDIATRIC PATIENT DEVELOPED SKIN REDNESS AFTER APPLICATION OF THE REFERENCED DRESSINGS TO PROTECT A PORT-A-CATH. THE ALLEGED SKIN REDNESS WAS REPORTEDLY 2CM X 2CM IN SIZE AND OCCURRED INSIDE THE DRESSING AREA ON THE CHEST. THE SKIN REDNESS APPEARED AFTER 3-4 DAYS OF WEAR OF THE MOST RECENTLY APPLIED DRESSING AND RESOLVED IN ONE WEEK. A SECOND MALE PEDIATRIC PATIENT DEVELOPED A SKIN RASH WITH ITCHING AFTER APPLICATION OF THE REFERENCED DRESSINGS TO PROTECT A PORT-A-CATH. THE ALLEGED RASH WAS REPORTEDLY 2CM X 2CM IN SIZE AND OCCURRED INSIDE THE DRESSING AREA ON THE UPPER CHEST. THE RASH APPEARED AFTER 3-4 DAYS OF W
Patient problems: Erythema; Rash; Skin Irritation; Unspecified Infection
MAUDE report 8941503 ↗
Other Dressing, wound, occlusive devices
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- DUODERM 187955Convatec, Purchasing Department · Dressing, Wound, Occlusive1 recall2,348 reports
- DUODERM 187660Convatec, Purchasing Department · Dressing, Wound, Occlusive207 reports
- DUODERM 187961Convatec, Purchasing Department · Dressing, Wound, Occlusive153 reports
- SAM Chest Seal CS203-ENSAM Medical Products · Dressing, Wound, Occlusive1 recall0 reports
- DUODERM 187662Convatec, Purchasing Department · Dressing, Wound, Occlusive43 reports
- ALLEVYN LIFE L 15.4X15.4 CTN10 66801069Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 reports
- ALLEVYN LIFE SACRUM (LARGE) PACK OF 10 66801307Smith & Nephew Medical Limited · Dressing, Wound, Occlusive28 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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