(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: what was the specific location of the rash on the body: all 4 patient had reactions inside of both arms and inner thighs, and some patients also had across waist at back.Does the reaction extend 1-2 inches beyond each tape or only 1 site of the tape: multiple areas.Rash was under arms, inner thighs, across back at waist.Rash was not systemic, rash was localized around tape.Were each of the 4 patients female and approximately 40 ¿ yes was the topical steroid cream prescribed or over the counter: treated with prescription topical steroids.Event dates: all 4 procedure dates were within the last quarter.No photos or patient demographic data is available.Please clarify "cut the skin away" mean - these are plastic surgery procedures.He uses a scalpel and scissors.The cases are big body lifts, removing a lot of skin.
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It was reported that the patient underwent a major body lift plastic procedure on unknown date and the topical skin adhesive was used.Following the procedure, the patient developed a rash and reaction was located inside of both arms and inner thighs, and/or across waist at back.Rash was not systemic but localized around tape.The patient was treated with prescription topical steroids.
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