[139191505]
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 (this report #, 2028403-2019-00002, 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) 2018 the first dermagraft was applied on the ulceration, secured with steri-strips, and covered with adaptic, gauze, and kerlix. The physician reported a couple days later, the patient began complaining of pain, itching, and burning around the ulcer, and on his follow up visit, was found to have swelling and erythema around the application site. The physician reported the dermagraft was no longer visible on the application site, and due to the appearance, a culture was taken of the ulcer and the patient was started on augmentin (for prophylaxis). The culture results grew staph a. The ulcer did not deteriorate and the patient improved. Treatment was changed to a collagen dressing. As per the physician, he reported he did not believe there was an infection during this event (or the subsequent two events, 2028403-2019-00002, and 2028403-2019-00003). Although the patient was prescribed antibiotics and was hospitalized during the second event (2028403-2019-00002), he stated it was for prophylaxis and not for treatment. He reported this event was an allergic reaction to the product, with each event occurring more rapidly after each subsequent application. He reported he will not apply dermagraft on this patient. The physician stated all thawing and rinsing instructions were followed as per the directions for use. He stated the event is related to the product, as each episode occurred after the application and improved or resolved once the product was removed, as well as with anti-histamine medication. The medical assessment conclusion for this event: this event is moderate in severity as the allergic reaction (allergic contact dermatitis) occurred after each application. Initially, the allergic contact dermatitis was localized to the ulceration site but began spreading up the ipsilateral leg and occurred more rapidly after the second application (2028403-2019-00002). The patient did not develop immediate reaction to dermagraft after this first application (this report #), but then became sensitized and developed similar and faster symptoms upon re-exposure (2028403-2019-00002 and 2028403-2019-00003). Prompt removal of dermagraft after the second and third application (2028403-2019-00002 and 2028403-2019-00003) and anti-histamines (benadryl) resulted in improvement and resolution of the allergic contact dermatitis. In agreement with the physician, all three events that occurred were not an infection but an allergic contact dermatitis. The clinical symptoms described (pain, burning, itching, redness, no deterioration of the ulceration) as well as rapid resolution of the symptoms with anti-histamines and removal of the etiologic agent, are typically seen with allergic contact dermatitis. Although the patient was hospitalized after the second application (2028403-2019-00002) and received medical treatment in the form of antibiotics for all three events, the physician reported it was prophylactically and not to treat an infection. This event did not result in death and no physical impairment or permanent injury resulted. Other than the allergic contact dermatitis, no other complications or symptoms occurred (infection or deterioration of the ulceration). The event resolved and the patient is doing well. This event is probably related to the product as it occurred after each application and resolved after the product was removed and treated with anti-histamine (benadryl). In addition, the symptoms recurred similarly and rapidly with each exposure to the product. Although not common, this event is expected, as an allergic reaction to dermagraft is possible. Severity: moderate, relatedness: probably related, expectedness: expected.
Patient Sequence No: 1, Text Type: D, B5