[20442593]
This mdr is for a patient event initially reported by the physician on (b)(6) 2015. Organogenesis (oi) director medical affairs received a telephone call on (b)(6) 2015 at 5pm est from organogenesis regional sales manager who was in the clinic with dr. (b)(6). Director medical affairs spoke with dr. (b)(6) directly, who stated that he had a patient treated with apligraf that displayed allergic, contact dermatitis type reaction following the second application of apligraf. Patient ((b)(6)) had a venous leg ulcer that was treated with apligraf and received two applications. The second apligraf was applied at least a month after the first application and at the follow-up visit, the patient presented with localized red, dermatitis like appearance to the peri-wound skin with erythema and blisters (but did not have active infection). The patient was placed on a course of steroids and apligraf and mepilex primary dressing were not reapplied. Symptomatic treatment with steroids was given for the local reaction and no systemic or metabolic effect was noted. The patient has since improved and progressed to healing. Dr. (b)(6) has used apligraf for many years and did not note any changes in his application protocol for this patient. The peri-wound area is cleansed with mild soap and water and the wound is rinsed with normal saline. Apligraf is applied with 1mm overlap to wound margins and affixed with steri-strips and a mepilex non-adhesive dressing.
Patient Sequence No: 1, Text Type: D, B5