Tegaderm™ 1657Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 30707387578313), received between Aug 15, 2018 and Jun 28, 2023 — classified as 1 death, 10 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A HOSPITAL REPORTED A 1.5CM X 1.5CM BURN-LIKE SKIN LESION, YELLOWISH WHITE TISSUE, CLEAR MARGINS, MEDIUM SEROUS EXUDATE, AND PERIPHERAL REDNESS ON AN 8-MONTH-OLD FEMALE PATIENT AFTER USE OF 1660R TEGADERM CHG. SYMPTOMS STARTED AFTER FIVE DAYS OF WEAR ON THE PATIENT'S RIGHT JUGULAR VEIN. THE CHG PAD WAS SLIGHTED SATURATED UPON DRESSING CHANGE AND THE IRRITATION WAS FOUND UNDER THE CHG PAD. UPON REMOVING THE DRESSING, THE PEDIATRIC PATIENT WAS CRYING. THERE WERE NO DIFFICULTIES REMOVING THE DRESSING. TOPICAL TREATMENT WHILE USING POLYURETHANE FOAM WITH SILVER, HYDROGEL, AND PORTABLE LOW POWER LASER THERAPY. ANESTHESIA WAS NOT REQUIRED FOR THE FOUR TREATMENTS OF LASER THERAPY. AFTER 48 HOURS OF THE INITIAL TREATMENT, TOPICAL HYDROGEL WAS FOLLOWED. THE PATIENT WAS DISCHARGED WITH HOME CARE AND THE SKIN IRRITATION IS HEALED.

  Patient problems: Fluid Discharge; Skin Discoloration

  MAUDE report 17221150 ↗
• InjuryNov 29, 2022Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  A HOSPITAL REPORTED AN INCIDENT INVOLVING A 62-YEAR-OLD MALE PATIENT. ON (B)(6) 2022, THE TEGADERM CHG DRESSING WAS USED TO SECURE THE PATIENT'S PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE LOCATED ON HIS BRACHIAL (DATE OF PICC LINE INSERTION WAS NOT REPORTED). THE AREA WAS CLEANSED WITH CHLOROPREP AND THE PICC LINE WAS STABILIZED WITH STAT-LOCK BEFORE THE DRESSING WAS PLACED. NO SKIN PROTECTANT WAS APPLIED ON THE AREA BEFORE THE DRESSING WAS PLACED. THE PATIENT RECEIVED IV FLUIDS AND OTHER UNSPECIFIED THERAPIES THROUGH THE PICC LINE. ON (B)(6) 2022, DURING AN OUTPATIENT VISIT FOR TREATMENT AND PICC LINE DRESSING CHANGE, THE DRESSING WAS NOTED WITH YELLOW DRAINAGE AND THE AREA WHERE THE CHLOROPREP WAS APPLIED FELT LIKE PITTING EDEMA. AFTER THE DRESSING WAS REMOVED, THE PATIENT'S SKIN WAS MOIST, WITH YELLOW PATCHES AND GRANULATION. THE AREA WAS TREATED WITH TOPICAL ANTIBIOTIC AND STEROID (CLOTRIMAZOLE/BACITRACIN/NEOMYCIN). THE ALLEGED INJURY RESOLVED AFTER ONE MONTH AND THE AREA IS SCARRED. THE PATIENT HAD NO PRE-EXISTING SKIN CONDITIONS AND THE DRESSING WAS APPLIED ON INTACT SKIN. NO ALLERGIES, MEDICAL HISTORY OR INTERVENTION REPORTED.

  Patient problems: Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 15882557 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY IN (B)(6) REPORTED A (B)(6)-YEAR-OLD FEMALE WITH AN IJ CVC LINE FOR ANTIBIOTIC DELIVERY DEVELOPED SKIN LESIONS (DENUDATION AND MACERATION) WITH USE OF A 1657R 3M¿ TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I. V. SECUREMENT DRESSING. THE DRESSING WAS ON FOR MORE THAN 24 HOURS. MULTIPLE DRESSINGS HAD BEEN APPLIED. PRIOR TO DRESSING APPLICATIONS, CHLOROPREP/CHG AND CAVILON¿ NO STING BARRIER FILM WERE USED. THE LESIONS, PRESENTED UNDER THE CHG GEL PAD, WERE NOTICED BY HOSPITAL STAFF AFTER CLEANING OF THE SITE. THE PATIENT HAD NO PRIOR HISTORY OF SKIN CONDITIONS OR SENSITIVITY TO ADHESIVE. TEGADERM¿ CHG WAS DISCONTINUED, CATHETER WAS REMOVED, AND A NEW LINE WAS PLACED. THE SKIN REACTION HEALED.

  Patient problems: Skin Irritation

  MAUDE report 9485076 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY IN (B)(6) REPORTED A (B)(6)-YEAR-OLD FEMALE WITH A IJ CVC LINE FOR ANTIBIOTIC DELIVER DEVELOPED SKIN LESIONS (ERYTHEMA AND PUSTULES) WITH USE OF A 1657R 3M¿ TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I. V. SECUREMENT DRESSING. THE DRESSING WAS ON FOR MORE THAN 7 DAYS. MULTIPLE DRESSINGS HAD BEEN APPLIED. PRIOR TO DRESSING APPLICATIONS, CHLOROPREP/CHG AND CAVILON¿ NO STING BARRIER FILM WERE USED. THE LESIONS PRESENTED UNDER THE CHG GEL PAD. THE PATIENT HAD NO PRIOR HISTORY OF SKIN CONDITIONS OR SENSITIVITY TO ADHESIVE. TEGADERM¿ CHG WAS DISCONTINUED, CATHETER WAS REMOVED, AND A NEW LINE WAS PLACED. THE SKIN REACTION HEALED.

  Patient problems: Erythema; Skin Irritation

  MAUDE report 9485012 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY IN (B)(6) REPORTED AN (B)(6)-YEAR-OLD FEMALE WITH A CVC, BRACH PICC LINE FOR ANTIBIOTIC DELIVER DEVELOPED SKIN LESIONS WITH USE OF A TEGADERM¿ DRESSING, 1657R. THE DRESSING WAS ON FOR 7 DAYS. MULTIPLE DRESSINGS HAD BEEN APPLIED. PRIOR TO DRESSING APPLICATIONS, CHLOROPREP/CHG, CHLORHEXIDINE GLUCONATE AND CAVILON¿ NO STING BARRIER FILM WERE USED. THE CHG PLATE WAS REPORTEDLY ADHERED TO THE PATIENT'S SKIN PRIOR TO REMOVAL. THE FACILITY ALLEGED WHEN THE TEGADERM¿ DRESSING WAS REMOVED, SOME OF THE PATIENT'S SKIN CAME OFF. THE LESIONS PRESENTED UNDER THE CHG GEL PAD. THE PATIENT HAD NO PRIOR HISTORY OF SKIN CONDITIONS OR SENSITIVITY TO ADHESIVE. TEGADERM¿ CHG WAS DISCONTINUED, CATHETER WAS REMOVED, AND A NEW LINE WAS PLACED. THE SKIN REACTION HEALED.

  Patient problems: Skin Irritation

  MAUDE report 9477671 ↗
• InjurySep 26, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  A NURSE ALLEGED THAT A MALE OUTPATIENT DEVELOPED A FUNGAL RASH/INFECTION ON THE LEFT INNER ARM UNDER A 3M¿ TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I.V. SECUREMENT DRESSING. THE DRESSING WAS USED TO PROTECT A BRACHIAL PICC LINE INSERTED FOR ANTIBIOTIC ADMINISTRATION. THE NURSE WAS UNSURE IF SKIN PREPARATION WAS CONDUCTED PRIOR TO DRESSING APPLICATION. THE RASH/INFECTION OCCURRED WITHIN 24 HOURS OF DRESSING APPLICATION. THE DRESSING WAS EXPOSED TO MOISTURE VIA DIAPHORESIS AND BATHING/SHOWERING DURING WEAR. THE CATHETER WAS STABILIZED WITH STAT-LOCK®. DIFLUCAN, ORAL, WAS PRESCRIBED FOR THE RASH. THE CATHETER REMAINED IN PLACE. THE PATIENT REPORTEDLY HAD NO PRE-EXISTING SKIN CONDITIONS OR ALLERGIES TO CHLORHEXIDINE GLUCONATE OR MEDICAL ADHESIVES.

  Patient problems: Erythema; Fungal Infection

  MAUDE report 9122425 ↗
• InjurySep 16, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  A NURSE REPORTED THAT PUS, A SMALL BLISTER AND SLIGHT ARM PAIN OCCURRED WITH TWO 1657 3M¿ TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I.V. SECUREMENT DRESSING CHANGES FOR A PATIENT WHO HAD OPEN-HEART SURGERY. THE DRESSING WAS APPLIED TO PROTECT A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) (DOUBLE-LUMEN) IN THE UPPER RIGHT ARM. THE PICC LINE WAS IN PLACE IN THE ARM FOR 1.5 MONTHS PRIOR TO THE ALLEGED SYMPTOMS. THE SMALL BLISTER WAS NEAR THE PICC LINE INSERTION SITE. WITH EACH DRESSING CHANGE, THE SKIN WAS PREPPED WITH A CHLORHEXIDINE SWAB AND ALLOWED TO DRY BEFORE DRESSING APPLICATION. THE PICC LINE WAS REMOVED AND A NEW PERIPHERAL ACCESS LINE WAS PLACED. THE PATIENT WAS REPORTED TO HAVE NO FEVER, NO ELEVATED WHITE BLOOD CELL COUNT OR ANY SIGN OF INFECTION. THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Injury; Irritation; Pain

  MAUDE report 9072187 ↗
• InjuryJul 11, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  A VASCULAR ACCESS NURSE SPECIALIST ALLEGED 3-4 OUTPATIENT PEDIATRIC PATIENTS (AGES AND GENDERS NOT SPECIFIED) EXPERIENCED IRRITATION AND/OR INFECTION RELATED TO THE USE OF 3M¿ TEGADERM¿ CHG I.V. SECUREMENT DRESSING. THE NURSE REPORTED ALL PATIENTS REQUIRED ADMISSION. SPECIFIC PATIENT TREATMENT DETAILS WERE NOT PROVIDED. A BIOPSY WAS PERFORMED FOR ONE FEMALE PATIENT WHERE FUNGUS MOLD AND (B)(6) WAS ALLEGEDLY GROWING AROUND THE DRESSING. THE NURSE INFORMED THIS ISSUE HAD BEEN NOTED IN THE SUMMER WHEN PATIENTS ARE OUT IN THE HEAT AND IN AND AROUND WATER. THE NURSE REPORTED AQUA GUARD IS SENT FOR PATIENTS TO USE FOR CENTRAL VENOUS LINES WHEN BATHING OR SHOWERING.

  Patient problems: Skin Irritation; Unspecified Infection

  MAUDE report 8781986 ↗
• InjuryFeb 7, 2019Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  A NURSE REPORTED AN INPATIENT WITH TOXIC EPIDERMAL NECROLYSIS HAD A LEFT INTERNAL JUGULAR (IJ) CATHETER IN PLACE DUE TO LIMITED VENOUS ACCESS. THE NURSE REPORTED ONE 1657 3M¿ TEGADERM CHG DRESSING WAS APPLIED TO THE SITE. THE SKIN AROUND THE INSERTION SITE WAS "NOT HEALTHY OR INTACT" PRIOR TO APPLICATION OF THE TEGADERM CHG DRESSING. THE NURSE REPORTED BIOPATCH HAD BEEN APPLIED TO THE SITE PRIOR TO APPLICATION OF THE TEGADERM CHG DRESSING. THE NURSE REPORTED THE PATIENT EXPERIENCED SKIN NECROSIS AROUND THE CATHETER INSERTION SITE AND THE PATIENT WILL REQUIRE SKIN GRAFTING.

  Patient problems: Necrosis

  MAUDE report 8316954 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL EMPLOYEE IN (B)(6) REPORTED 10 PATIENTS EXPERIENCED ULCERATION AT THEIR PICC CATHETER INSERTION SITES. SECURACATH® SECUREMENT /STABILIZATION DEVICE AND 1657R 3M¿ TEGADERM¿ CHG CHLORHEXIDINE GLUCONATE I. V. SECUREMENT DRESSING WERE REPORTEDLY APPLIED TO ALL THE PICC CATHETER SITES. ALL 10 PATIENTS REQUIRED PICC CATHETER REMOVAL. THE PICC CATHETER SITES ALL REPORTEDLY HEALED WITH SOME "DRESSING MANAGEMENT".

  Patient problems: Ulceration

  MAUDE report 8240442 ↗
• DeathAug 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED A VERY SICK POST-OPERATIVE HEART PATIENT IN ICU HAD A CORDIS CATHETER PLACED IN THE RIGHT INTERNAL JUGULAR VEIN. A 1657 3M¿ TEGADERM¿ CHG DRESSING WAS REPORTEDLY APPLIED TO THE SITE. AFTER 3-4 DAYS OF APPLICATION, THE DRESSING WAS REMOVED AND DISCARDED. THE PATIENT EXPERIENCED SKIN REMOVAL AND PUS WAS ALLEGEDLY FOUND AT THE INSERTION SITE WHEN THE PRODUCT WAS REMOVED. THE AREA WAS CLEANSED, THE CORDIS CATHETER WAS REMOVED AND BACITRACIN OINTMENT WAS APPLIED TO THE SITE. THE PATIENT'S WBC WAS ELEVATED SO HIS ARTERIAL LINE WAS ALSO REPORTEDLY REMOVED. THE ARTERIAL LINE ALSO HAD A TEGADERM¿ CHG DRESSING APPLIED TO THE SITE AND NO ISSUE OCCURRED AT THE ARTERIAL SITE. THE RIGHT IJ SITE WAS HEALING AND THE WBC COUNTS WERE DOWN WHEN THE PATIENT WAS DISCHARGED FROM ICU. THE VERY SICK PATIENT REPORTEDLY EXPIRED ON OR AROUND (B)(6) 2018 NOT RELATED TO HIS CORDIS SITE ISSUE. THE CAUSE OF DEATH WAS LISTED AS HEART FAILURE. THE NURSE REPORTED THIS WAS A VERY SICK PATIENT AND THE DEATH WAS "DEFINITELY NOT RELATED TO APPLICATION OF THE TEGADERM¿ CHG DRESSING".

  Patient problems: Death; Purulent Discharge; Skin Tears

  MAUDE report 7785866 ↗