Ioban™ 2 6650EZRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 30707387507351), received between Nov 18, 2020 and Oct 16, 2023 — classified as 19 injuries.

The most frequently reported specific device problem is “Human-Device Interface Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL REPORTED TWO PATIENTS ALLEGEDLY EXPERIENCED SKIN TEARS WITH REMOVAL OF THE 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE, 6650EZ. THE PHYSICIAN CONFIRMED NO PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Skin Tears

  MAUDE report 17940279 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL REPORTED A SURGICAL PATIENT UNDERWENT A FOUR-TO-FIVE-HOUR FIRST RIB RESECTION PROCEDURE. THE PATIENT'S SKIN WAS PREPPED WITH CHLORAPREP AND A IOBAN DRAPE WAS USED AS PART OF THE STERILE DRAPE. THE DRAPE WAS PLACED ON THE PATIENT'S LEFT SIDE OF THE NECK AND UPPER CHEST AREA. POSTOPERATIVE THE PATIENT REPORTED BURNING TO THE SURGICAL AREA. AFTER APPROXIMATELY EIGHT TO TWELVE HOURS AFTER APPLICATION THE SKIN WAS ASSESSED. THE SURGEON ALLEGED BLISTERS AND INITIALLY THOUGHT IT WAS A BURN FROM THE OPERATING ROOM LIGHTS. A PLASTIC SURGEON WAS CONSULTED, SILVADENE OINTMENT FOLLOWED BY STEROID INJECTIONS AND SCAR EXCISION WERE PERFORMED. THE LIGHTS WERE INSPECTED ON THE MAX INTENSITY; ALTHOUGH THEY WERE UNABLE TO CONFIRM IF THE LIGHTS DID INDEED CAUSE THE BURN LIKE SYMPTOMS. THE PLASTIC SURGEON SEEMS TO THINK THIS MAY BE A CHEMICAL REACTION FROM EITHER THE IOBAN DRAPE OR COMBINATION OF THE DRAPE AND CHLORAPREP. THE PATIENT IS DOING WELL AND IS PLEASED WITH THE RESULTS OF THE SCAR EXCISION SURGERY.

  Patient problems: Blister

  MAUDE report 17095106 ↗
• InjuryMay 19, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A CUSTOMER ALLEGED TWO PATIENT SAFETY EVENTS OF SKIN TEARS OCCURRED WITH THE REMOVAL OF THE 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE, 6650EZ. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Tears

  MAUDE report 16963825 ↗
• InjuryMay 11, 2023Human-Device Interface Problem; Human-Device Interface Problem

  REPORT RECEIVED VIA MEDWATCH FORM 4600610000-2023-8004. A HOSPITAL HEALTH REPRESENTATIVE REPORTED A 62-YEAR-OLD MALE ALLEGEDLY EXPERIENCED A 2 CM SUPERFICIAL EPIDERMAL SKIN STRIP UPON POST OPERATIVE REMOVAL OF THE 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE, 6650EZ LOT 33NTJJ. NO OTHER SKIN WAS PEELED AWAY FROM THE PATIENT WITH THE 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE, AND NORMAL SKIN EDGES WERE REPORTEDLY STILL PRESENT AT THE INCISION SITE. THE WOUND WAS CLOSED, AND 0.5-1ML OF BACITRACIN ANTIBIOTIC OINTMENT 500 UNITS/GRAM WAS APPLIED TO TREAT THE AREA. DERMABOND ADVANCED® TOPICAL SKIN ADHESIVE WAS PLACED ALONG THE INCISION SITE WITH TELFA DRESSING AND 3M¿ MEDIPORE¿ SURGICAL TAPE.

  Patient problems: Skin Tears

  MAUDE report 16916943 ↗
• InjuryMar 21, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A HOSPITAL ALLEGED AN 92-YEAR-OLD FEMALE EXPERIENCED A RIGHT LATERAL HIP SKIN TEAR UPON POSTOPERATIVE REMOVAL OF THE 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE, 6650EZ. THE SKIN TEAR WAS NOTED AS A MINOR INJURY THAT REQUIRED MEDICAL TREATMENT DESCRIBED AS "DRESSINGS APPLIED TO KEEP THE SKIN TEAR SITE CLEAN AND HOPEFULLY FREE OF INFECTION."

  Patient problems: Skin Tears

  MAUDE report 16582321 ↗
• InjurySep 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  A 8-MONTH-OLD EXPERIENCED A CHEST SKIN TEAR WITH POST OPERATIVE REMOVAL OF A LINEN DRAPE WITH 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE 6650EZ THAT WAS ALLEGEDLY STICKIER THAN USUAL. THE CLINICIAN NOTED THAT A SMALL ROUND AREA OF EPIDERMIS WAS REMOVED, AND DURING SURGERY NOTHING WAS TAPED OR PLACED ON TOP OF THE LOCATION WHERE THE SKIN TEAR OCCURRED. SALINE WAS APPLIED TO AID IN DRAPE REMOVAL, AND GAUZE WAS APPLIED TO THE AREA WITH NO MEDICATION OR TREATMENT PROVIDED. NO MEDICAL INTERVENTIONS WERE PROVIDED.

  Patient problems: Skin Tears

  MAUDE report 15456789 ↗
• InjurySep 20, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  A 6-MONTH-OLD EXPERIENCED A CHEST SKIN TEAR WITH POST OPERATIVE REMOVAL OF A LINEN DRAPE WITH 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE 6650EZ THAT WAS ALLEGEDLY STICKIER THAN USUAL. SALINE WAS APPLIED TO AID IN DRAPE REMOVAL, AND GAUZE WAS APPLIED TO THE AREA WITH NO MEDICATION OR TREATMENT PROVIDED. THE CUSTOMER DISCONTINUED USE OF THE 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE 6650EZ IN PEDIATRIC PATIENTS. NO MEDICAL INTERVENTIONS WERE PROVIDED.

  Patient problems: Skin Tears

  MAUDE report 15456651 ↗
• InjuryAug 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  A CUSTOMER ALLEGED A SKIN TEAR/SKIN REMOVAL WITH REMOVAL OF A 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE POST OPERATIVE TOTAL KNEE REPLACEMENT. TREATMENT INCLUDES WEEKLY APPLICATION OF SILVADENE® CREAM AND KEFLEX® FOR THREE WEEKS. THE CUSTOMER BRUISES EASILY AND EXPERIENCES PAIN WITH DRESSING CHANGES. TWO TABLETS OF 650MG TYLENOL ARE TAKEN TWICE A DAY FOR PAIN. THE WOUND IS HEALING; HOWEVER, PHYSICAL THERAPY WAS THIS INITIALLY DELAYED. RANGE OF MOTION HAS NOW IMPROVED.

  Patient problems: Pain; Skin Tears

  MAUDE report 15222261 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL MATERIALS MANAGER OF SURGICAL SERVICES REPORTED THAT A DIABETIC PATIENT DEVELOPED BLISTERS ON A LEG WITH USE OF 3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE WAS APPLIED FOR A SURGICAL PROCEDURE. THE PATIENT WAS SEEN BY THE HOSPITAL SURGEON AND WAS PROVIDED AN UNSPECIFIED OINTMENT TO TREAT THE BLISTERS AND WAS INSTRUCTED TO FOLLOW-UP IN THE OFFICE. FURTHER INFORMATION RECEIVED FROM THE VASCULAR SURGERY NURSE WAS THAT THE DRAPE WAS PUT ON A STRAIGHT LEG AND THEN THE LEG WAS BENT FOR ACCESS DURING THE THREE-TO-FOUR-HOUR PROCEDURE. 3M DURAPREP SURGICAL SOLUTION WAS APPLIED FOR SURGICAL SKIN PREPARATION. UPON REMOVING THE DRAPE, A BURN/BLISTER WAS NOTICED.

  Patient problems: Blister; Burn(s)

  MAUDE report 12962170 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL MATERIALS MANAGER OF SURGICAL SERVICES REPORTED THAT A PATIENT DEVELOPED BLISTERS ON A LEG WITH USE OF 3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE WAS APPLIED FOR A SURGICAL PROCEDURE. THE PATIENT WAS SEEN BY THE HOSPITAL SURGEON AND WAS PROVIDED AN UNSPECIFIED OINTMENT TO TREAT THE BLISTERS AND WAS INSTRUCTED TO FOLLOW-UP IN THE OFFICE. 3M DURAPREP SURGICAL SOLUTION WAS APPLIED FOR SURGICAL SKIN PREPARATION. VASCULAR SURGERY NURSE INFORMED THAT UPON REMOVING THE DRAPE, A BURN/BLISTER WAS NOTICED.

  Patient problems: Blister; Burn(s)

  MAUDE report 12962162 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL MATERIALS MANAGER OF SURGICAL SERVICES REPORTED THAT A PATIENT DEVELOPED BLISTERS ON A LEG WITH USE OF 3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE WAS APPLIED FOR A SURGICAL PROCEDURE. THE PATIENT WAS SEEN BY THE HOSPITAL SURGEON AND WAS PROVIDED AN UNSPECIFIED OINTMENT TO TREAT THE BLISTERS AND WAS INSTRUCTED TO FOLLOW-UP IN THE OFFICE. 3M DURAPREP SURGICAL SOLUTION WAS APPLIED FOR SURGICAL SKIN PREPARATION. VASCULAR SURGERY NURSE INFORMED THAT UPON REMOVING THE DRAPE, A BURN/BLISTER WAS NOTICED.

  Patient problems: Blister; Burn(s)

  MAUDE report 12962154 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OPERATING ROOM MANAGER REPORTED SKIN REDNESS, BLISTERS, BURNING, PAIN, AND A SKIN TEAR ON THE LEFT CHEST WALL OF AN INFANT. THE 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE WAS ON THE SKIN FOR MORE THAN THREE HOURS. WOUND CARE TEAM INTERVENTION WAS REQUIRED. CHLORHEXIDINE GLUCONATE WAS APPLIED FOR SURGICAL SKIN PREPARATION. DERMABOND® AND MEPILEX® DRESSING WERE APPLIED POST-OPERATIVELY.

  Patient problems: Blister; Erythema; Pain; Skin Burning Sensation; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 11330356 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OPERATING ROOM MANAGER REPORTED SKIN REDNESS, BLISTERS, BURNING, PAIN, AND A SKIN TEAR ON THE BILATERAL CHEST WALL OF AN INFANT. THE 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE WAS ON THE SKIN FOR MORE THAN THREE HOURS. WOUND CARE TEAM INTERVENTION WAS REQUIRED. CHLORHEXIDINE GLUCONATE WAS APPLIED FOR SURGICAL SKIN PREPARATION. DERMABOND® AND MEPILEX® DRESSING WERE APPLIED POST-OPERATIVELY.

  Patient problems: Blister; Erythema; Pain; Skin Burning Sensation; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 11330303 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OPERATING ROOM MANAGER REPORTED SKIN REDNESS, BLISTERS, BURNING, PAIN, AND A SKIN TEAR ON THE BILATERAL CHEST WALL OF AN INFANT. THE ABRASION WAS LARGER ON THE LEFT WALL. THE 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE WAS ON THE SKIN FOR MORE THAN THREE HOURS. WOUND CARE TEAM INTERVENTION WAS REQUIRED. CHLORHEXIDINE GLUCONATE WAS APPLIED FOR SURGICAL SKIN PREPARATION. DERMABOND® AND MEPILEX® DRESSING WERE APPLIED POST-OPERATIVELY.

  Patient problems: Blister; Erythema; Pain; Skin Burning Sensation; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 11330224 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THE PUMP WAS RESET, AND THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER.

  Patient problems: Blister; Erythema; Pain; Skin Burning Sensation; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 11330069 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OPERATING ROOM MANAGER REPORTED SKIN REDNESS, BLISTERS, BURNING, PAIN AND A SKIN TEAR ON THE BILATERAL CHEST WALL OF AN INFANT. THE ABRASION WAS LARGER ON THE LEFT WALL. THE 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE WAS ON THE SKIN FOR MORE THAN THREE HOURS. WOUND CARE TEAM INTERVENTION WAS REQUIRED. CHLORHEXIDINE GLUCONATE WAS APPLIED FOR SURGICAL SKIN PREPARATION. DERMABOND® AND MEPILEX® DRESSING WERE APPLIED POST-OPERATIVELY.

  Patient problems: Blister; Erythema; Pain; Skin Burning Sensation; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 11330037 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT ON 03DEC2020 FROM CLINICAL SPECIALIST REPORTING SKIN BURN/SKIN TEAR ON THE CHEST OF AN (B)(6) MONTH OLD INFANT. CUSTOMER USES CHLOROPREP AS SURGICAL PREP. THE CUSTOMER USES DERMABOND AND MEPILEX ON CHEST POST OP. NO OTHER INFORMATION FOR THIS PATIENT WAS RECEIVED. 4 OTHER INCIDENTS WERE MENTIONED IN THIS REPORT - HOWEVER, NO PATIENT SPECIFIC INFORMATION FOR THOSE INCIDENTS WAS REPORTED.

  Patient problems: Blister; Erythema; Pain; Skin Burning Sensation; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 11067550 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT ON 03DEC2020 FROM CLINICAL SPECIALIST REPORTING SKIN BURN/SKIN TEAR ON THE CHEST OF AN (B)(6) DAY OLD INFANT. CUSTOMER USES CHLOROPREP AS SURGICAL PREP. THE CUSTOMER USES DERMABOND AND MEPILEX ON CHEST POST OP. NO OTHER INFORMATION FOR THIS PATIENT WAS RECEIVED. 4 OTHER INCIDENTS WERE MENTIONED IN THIS REPORT - HOWEVER, THERE WAS NO PATIENT SPECIFIC INFORMATION FOR THOSE INCIDENTS.

  Patient problems: Blister; Erythema; Pain; Skin Burning Sensation; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 11067529 ↗
• InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ALLERGIST REPORTED THAT A PATIENT EXPERIENCED SKIN REDNESS, ITCHINESS, BURNING SENSATION AND PAIN AFTER A SURGICAL PROCEDURE IN (B)(6) 2020 WHERE A 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE, CATALOG 6650EZ, WAS PLACED. CHLORHEXIDINE GLUCONATE WAS APPLIED AS A SKIN PREPARATION BEFORE THE DRAPE WAS PLACED. THE DRAPE WAS IN PLACE FOR 24-HOURS BEFORE THE SYMPTOMS BEGAN. TYPE OF SURGERY PERFORMED AND ANATOMICAL LOCATION OF THE DRAPE WAS NOT REPORTED. A COURSE OF PREDNISONE WAS PRESCRIBED, TAKEN LESS THAN A WEEK, AND 2.5% HYDROCORTISONE CREAM WAS APPLIED FOR ONE WEEK TO THE AFFECTED AREA. THE SYMPTOMS FULLY RESOLVED WITHIN ONE TO TWO WEEKS.

  Patient problems: Pain; Skin Burning Sensation; Skin Inflammation/ Irritation

  MAUDE report 10864883 ↗