OPSITE FLEXIGRID USA 6X7CM-CARTON OF 100 66024628Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05000223415402), received between Nov 10, 2020 and Nov 22, 2024 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, DURING TREATMENT, ONE (1) OPSITE FLEXIGRID 6X7CM CTN 100 CAUSED ULCERATION, BLISTERING AND REDNESS ON PATIENT'S HAND. TREATMENT WAS COMPLETED BY APPLYING FUSIDIC ACID TOPICALLY. NO FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Blister; Skin Inflammation/ Irritation; Ulcer

  MAUDE report 20759834 ↗
• InjuryOct 12, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, ACCORDING TO THE HOSPITAL REPORT ON (B)(6) 2024 AT 16:00 THE NURSE IN THE INFUSION FOUND THE CHILD'S ELBOW AROUND THE INDWELLING NEEDLE SKIN HAD VISIBLE RED RASH, PART OF THE FUSION, PROTRUDING FROM THE SKIN. THE INDWELLING NEEDLE WAS PUNCTURED ON 14-SEPT. NURSE IMMEDIATELY REMOVED THE NEEDLE PATCH OPSITE FLEXIGRID 6X7CM AND STERILIZED THE SKIN, THEN REPLACED THE FILM AFTER IT DRIED. NURSE TOLD THE DOCTOR ON DUTY TO CONTINUE TO OBSERVE THE SKIN RASH SITUATION AND STRICTLY HAND OVER TO THE NURSE. AT 20:00, THE NURSE ON THE NIGHT SHIFT, FOUND THAT SMALL RED HERPES APPEARED ON THE SKIN AT THE PLACE OF THE INDWELLING NEEDLE PATCH AND IMMEDIATELY REMOVED THE NEEDLE PATCH AND STERILIZED THE SKIN. THE FOLLOWING MORNING, DERMATOLOGY CONSULTATION WAS REQUESTED; A LARGE NUMBER OF ERYTHEMATOUS SPOTS AND PAPULES WERE SEEN ON THE LEFT ELBOW. DIAGNOSIS: DERMATITIS, WET COMPRESS WITH SODIUM CHLORIDE INJECTION THREE TIMES A DAY; TOPICAL APPLICATION OF DINAID CREAM TWICE A DAY; TOPICAL APPLICATION OF FUSIDIC ACID CREAM TWICE A DAY. TREATMENT PLAN: THE CHILD APPEARED LEFT ELBOW SKIN RASH, COMBINED WITH THE DERMATOLOGY CONSULTATION, ADDITIONAL DIAGNOSIS: DERMATITIS, TO BE SALINE

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 20435531 ↗
• MalfunctionMay 5, 2022Contamination; Contamination

  IT WAS REPORTED THAT, DURING TREATMENT, SPOTS ON THE BACKING PAPER OF A BOX OF OPSITE FLEXIGRID 6X7CM DRESSINGS WERE OBSERVED. IT IS UNKNOWN HOW TREATMENT WAS COMPLETED. A DELAY OF LESS THAN 30 MIN WAS CAUSED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291826 ↗
• MalfunctionMay 5, 2022Contamination; Contamination

  IT WAS REPORTED THAT, DURING WOUND TREATMENT, THERE WERE MANY BLACK SPOTS IN THE FILM AFTER OPENING THE PACKAGE. IT WAS FOUND IN SIX (6) BOXES OF OPSITE FLEXIGRID 6X7CM CTN 100. TREATMENT WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT IS FINE AND WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291725 ↗
• MalfunctionApr 26, 2022Contamination; Contamination

  IT WAS REPORTED THAT, WHEN THE PACKAGE OF AN OPSITE FLEXIGRID 6X7CM CTN 100 WAS OPENED, SEVERAL BLACK STAINS WERE FOUND ON THE DRESSING. AS THIS WAS NOTICED UPON SET-UP OR INSPECTION, THE PATIENT WAS NOT INVOLVED AT THAT MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14210210 ↗
• MalfunctionMar 9, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT WHEN REPLACING THE FILM FOR THE PATIENT, IT WAS DIFFICULT TO TEAR OFF THE PROTECTIVE PAPER AFTER THE FILM APPLIED TO THE SKIN. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13715782 ↗
• MalfunctionSep 29, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT, DURING WOUND TREATMENT, IT WAS IMPOSSIBLE TO TAKE THE DRESSING OUT FROM THE POUCH OF A OPSITE FLEXIGRID 6X7CM CTN 100 BECAUSE THE FILM ADHERED TO THE INSIDE THE POUCH. IT WAS FOUND IN 2 DRESSINGS IN THE CARTON. TREATMENT WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12551013 ↗
• InjuryJun 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT, AFTER REMOVING OPSITE FLEXIGRID 6X7 CM CTN 100, THE PATIENT EXPERIENCED RED AND SWOLLEN SKIN WITH ITCHY SENSATION. THESE ADVERSE EFFECTS WERE TREATED WITH A MAGNESIUM SULFATE INJECTION. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Erythema; Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 11921042 ↗
• MalfunctionMar 16, 2021Loss of or Failure to Bond; Difficult to Remove; Loss of or Failure to Bond; Difficult to Remove

  IT WAS REPORTED THAT, THE TOP PLASTIC FILM OF AN OPSITE FLEXIGRID 6X7CM CTN 100IS DIFFICULT OR EVEN IMPOSSIBLE TO REMOVE AFTER THE APPLICATION OF THE OPSITE DRESSINGS, AND OFTEN THE DRESSING DOES NOT REMAIN IN PLACE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11493020 ↗
• MalfunctionJan 8, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT CUSTOMER AFTER GETTING A TATTOO USED OPSITE 6X7 TO TRY AND COVER HER PIECE AND THE ENDS KEPT CURLING UP, CUSTOMER USED HOSPITAL TAPE TO HOLD THEM DOWN, HOWEVER THAT CAUSED THE FILM TO COME OFF FURTHER THEN CUSTOMER USED OPSITE 10X12 TO ENSURE IT WAS FULLY COVERED AND THE SECOND SEALED THAT HOWEVER CUSTOMER STILL HAS A LARGE PIECE THAT HAS NOT STUCK DOWN. NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139694 ↗
• MalfunctionDec 30, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT, DURING TREATMENT WITH OPSITE FILM, THE DRESSING FELL OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THERE WAS A DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096320 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WERE MANY SMALL TRANSPARENT BLISTERS AROUND THE PART COVERED BY THE OPSITE FLEXIGRID DRESSING. THE TRANSPARENT DRESSING WAS REMOVED IMMEDIATELY, THE INDWELLING NEEDLE WAS REMOVED, AND THEN THE IODINE COMPLEX WAS USED AND KEEP THE LOCAL DRY.

  Patient problems: Blister

  MAUDE report 10984618 ↗
• MalfunctionNov 10, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT WHEN THEY OPENED THE BOX NOTICED THAT ONE OF THE DRESSING DID NOT HAVE ADHESIVE ON IT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10819722 ↗