[16449884]
This unsolicited device case from united states was received on (b)(4) 2013 form a non-healthcare professional. This case concerns a (b)(6) male pt who expired after grafting with epicel cultured epidermal autografts (epicel). It was reported that the pt was not allergic to vancomycin, amikacin, amphotericin b. The pt's concomitant medications included silver nitrate solution for microbial wound infection. No medical history, past drugs or concurrent conditions were reported. On (b)(6) 2012, the pt sustained 99 percent of total body surface area (tbsa) thermal burns and the same day, he was hospitalized. The pt had wound infection and wound culture performed on (b)(6) 2012 grew gram negative rods (gnr, 2+). On (b)(6) 2012 (at 15:00 pm), biopsies were performed at right anterior thigh (tube number: 1 and 2). It was reported that the pt had no systemic microbial infection. On (b)(6) 2012 and (b)(6) 2013, respectively, the pt was grafted with 48 grafts of epicel cultured epidermal autografts (batch/lot number ee01646 for the grafts used on (b)(6) 2012 and expiration date: 11/30/2012) on an unspecified location for thermal burn. On (b)(6) 2013 (one month following third grafting with epicel cultured epidermal autografts), the pt died due to an unreported cause. Corrective treatment: unk. Outcome: fatal. A pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4) and results were pending for the same. Additional information was received on (b)(4) 2013 in the form of a biopsy transmittal form. The pt's demographics (gender and age), details of thermal burns, biopsy details and concurrent medication of silver nitrate solution were added. The text was amended accordingly.
Patient Sequence No: 1, Text Type: D, B5