Apligraf 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00618474000008), received between Jun 7, 2018 and Mar 21, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, (B)(6) YEAR OLD PATIENT, MG, RECEIVED APPLICATION OF APLIGRAF ON A WOUND ORIGINALLY CAUSED BY TRIPPING ON HER WALKER ON (B)(6) 2018. THE ORIGINAL WOUND, A RIGHT LOWER EXTREMITY LACERATION WAS SUTURED IN THE ER THE SAME DAY, THE PATIENT WAS GIVEN A TETANUS BOOSTER AND ANCEF WHILE IN THE ER AND DISCHARGED ON A COURSE OF ORAL KEFLEX. ON (B)(6) 2018 THE PATIENT FOLLOWED UP IN THE WOUND CARE CENTER AND WAS FOUND TO HAVE NECROSIS OF THE WOUND SITE AND DEHISCED LACERATION. THE PATIENT WAS THEN TREATED WEEKLY IN THE WOUND CARE CENTER WITH SERIAL DEBRIDEMENTS, DAKIN'S SOLUTION AND UNNA BOOT COMPRESSION DUE TO SWELLING. ON (B)(6) 2019, THE WOUND WAS IMPROVING WITH GOOD GRANULATION TISSUE AND NO SIGNS OF INFECTION. ON (B)(6) 2019, THE WOUND WAS DEBRIDED AND APLIGRAF WAS APPLIED ON A PORTION OF THE WOUND SINCE THE WOUND WAS LARGER THAN THE SIZE OF THE APLIGRAF. THE APLIGRAF WAS SECURED WITH STERI-STRIPS, COVERED WITH WOUND VEIL, SALINE MOISTENED GAUZE AND KLING. ON (B)(6)2019, THE PATIENT CALLED THE WOUND CARE CENTER COMPLAINING OF FEVERS AND RIGHT LOWER EXTREMITY WARMTH AND ERYTHEMA AND WAS TOLD TO GO TO THE ER. THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF RIGHT LOWER EXTREMIT

  Patient problems: Cellulitis

  MAUDE report 8439432 ↗
• InjuryJun 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, (B)(+), ETB, RECEIVED HIS FIRST APPLICATION OF APLIGRAF ON HIS RIGHT LOWER EXTREMITY FOR MIXED POST-SURGICAL AND VENOUS ULCERATIONS. ON THAT DAY THE PATIENT WAS SEEN AT THE WOUND CARE CENTER AND THE ULCERATIONS WERE DEBRIDED. IT WAS REPORTED THE ULCERATIONS APPEARED PUNCHED OUT WITH A NECROTIC WOUND BED, WHICH UPON DEBRIDEMENT, REVEALED A RED AND GRANULATING WOUND BASE THAT WAS FULL THICKNESS. AFTER THE DEBRIDEMENT APLIGRAF WAS APPLIED AND THE SITE WAS COVERED WITH NONADHERENT, HYDROFERA BLUE, GAUZE, KERLIX, AND 3M LIGHT TWO-LAYER COMPRESSION. THE PATIENT WAS TOLD TO KEEP THE DRESSINGS INTACT UNTIL HIS NEXT FOLLOW UP VISIT ONE WEEK LATER.ON (B)(6) 2018, THE PATIENT WENT TO THE EMERGENCY DEPARTMENT ON HIS OWN ACCORD DUE TO COMPLAINTS OF PAIN AND ODOR FROM THE RIGHT LOWER EXTREMITY. THE PATIENT WAS ADMITTED AND THE DRESSINGS WERE REMOVED. THE CLINICIAN WHO WAS TREATING THE PATIENT'S WOUNDS REPORTED THERE WAS NO DOCUMENTATION NOTING WHETHER APLIGRAF WAS STILL VISIBLE UPON REMOVAL OF THE DRESSINGS. THE TREATING CLINICIAN STATED FROM READING THE NOTES THAT THE FINAL WOUND CULTURE WAS STILL PENDING, BUT SO FAR, REVEALED A POLYMICROBIAL RESULT. SHE ALSO REPORTED BOTH BLOO

  Patient problems: Bacterial Infection

  MAUDE report 7578358 ↗