Dermagraft 1Recalls & reported problems
Organogenesis Inc. · Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot. · Class 3
Data updated Oct 18, 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 00618474000015), received between Mar 19, 2019 and Mar 19, 2019 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ORGANOGENESIS WAS NOTIFIED ON FEBRUARY 22, 2019 OF AN ADVERSE EVENT FOR A SINGLE PATIENT THAT ACTUALLY INCLUDED THREE SEPARATE ADVERSE EVENTS TO BE REPORTED SEPARATELY (2028403-2019-00001, THIS REPORT #, AND 2028403-2019-00003). FOR THIS EVENT, THE PATIENT PRESENTED WITH A PLANTAR SURFACE FOOT ULCERATION THAT HAS BEEN PRESENT FOR SEVERAL MONTHS AND HAS BEEN TREATED WITH DIFFERENT PRODUCTS SUCH AS COLLAGEN AND OTHER GRAFTS. THE PATIENT RECEIVED THREE SEPARATE DERMAGRAFT APPLICATIONS ON THE ULCERATION, AND HE DEVELOPED AN ALLERGIC REACTION AFTER EACH ONE. THE EVENT WAS REPORTED AFTER THE THIRD DERMAGRAFT APPLICATION (2028403-2019-00003). ON (B)(6) 2019, THE SECOND DERMAGRAFT WAS APPLIED ON THE ULCERATION, SECURED WITH STERI-STRIPS, AND COVERED WITH ADAPTIC, GAUZE, AND KERLIX. LESS THAN A DAY LATER, THE PATIENT BEGAN DEVELOPING SIMILAR SYMPTOMS OF PAIN, ITCHING, BURNING, AND ERYTHEMA AROUND THE ULCER SITE. THE PATIENT DECIDED TO GO TO THE ER AND WAS HOSPITALIZED FOR A DAY OR TWO AND TREATED WITH ANTIBIOTICS. THE DERMAGRAFT WAS REMOVED DURING THE HOSPITAL ADMISSION. THE PHYSICIAN REPORTED THE PATIENT ONLY WENT TO THE ER BECAUSE THE PATIENT BELIEVED HIS PHYSICIAN WAS NOT IN HIS OFFICE A
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 8432464 ↗
Other Cultured Human Cell Skin Dressing devices
- Apligraf 1Organogenesis Inc. · Cultured Human Cell Skin Dressing2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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