[139203216]
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, 2028403-2019-00002, and this report #). 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 (this report #). On (b)(6) 2019, the third dermagraft was applied on the ulceration, secured with steri-strips, and covered with adaptic, gauze, and kerlix. Less than 24 hours later, the patient began developing identical symptoms of pain, itching, burning, and erythema. The physician removed dermagraft, and applied a collagen dressing. The physician reported he prescribed zyvox for prophylaxis, but did not think it was infected. He stated the patient took benadryl, and on saturday morning, the symptoms had almost resolved and the patient was doing much better. The ulceration did not worsen. As per the physician, he reported he did not believe there was an infection during this event (or the other two events). 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 all three events were an allergic reaction to the product, with each event occurring more rapidly after each subsequent application. The physician reported he will not reapply the product to this patient. The physician stated all thawing and rinsing instructions were followed as per the directions for use. He stated all three events are 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 (2028403-2019-00001), but then became sensitized and developed similar and faster symptoms upon re-exposure (2028403-2019-00002 and this report #). Prompt removal of dermagraft after the second and third application (2028403-2019-00002 and this report #) 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. All three events are probably related to the product as they 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