Regulatory specialist had a phone conversation with the end consumer on 3/21/17 related to call 40250 where the end consumer was broke out with a rash.The end consumer stated the rash appeared the next day after the initial use of the arm sling.She noticed the rash after her pain medication had worn off.She stated her arm was red and very itchy resulting in welts and scaling of the skin on her arm.Additional treatment was required, the end consumer followed up with her doctor and received a steroid shot.The end consumer stated she has a medical condition called lupus and has very sensitive skin resulting in a rash and or an allergic reaction each time she has had any surgery's in the past.The complaint sample was returned, the product is a light blue 10105 sling.The product shows sign of wear/use, there was no corrective action required at this time due to no manufacturing issues being found.Sensitivity to materials vary from person to person however, there is no latex in the product.The root cause was determined to be that the end user is highly sensitive to various materials due to a medical condition.Between, january 1, 2015 - march 30, 2017 there have been (b)(4) units sold and no complaints reported for the 10105 arm sling product related to a rash and or an allergic reaction.No further information is available at this time.We will provide a follow up report if additional information becomes available.
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