Weight: no information was provided.Lot #: product lot # not provided.Manufacture date: no lot # was provided, therefore device manufacture date is unknown.Health professional: initial reporter's occupation was not provided.The device was not returned for evaluation.Product lot # was not provided.Primary packaging indicates that if discomfort or pain results, persists or increases, discontinue use and consult a physician.Packaging also indicates how to wear.Complaint history was reviewed over the past 24 months for the products global sales code (gsc) of (b)(4) and the reported failure.No trends were observed.A follow up report will be submitted if device is received and analyzed.
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Product was received from the consumer on april 19, 2019.The returned product was analyzed.Updated method, results, and conclusion codes.The device was returned and evaluated.No primary packaging was returned, therefore, product lot # remains unknown.The product was inspected and looked new in appearance.There were no visual defects noted with exception of sewing thread which was not trimmed.Product was as expected.Some consumers may have sensitivities to neoprene.The primary packaging does contain a caution statement for neoprene as follows: caution: some individuals, may be sensitive to neoprene or neoprene-blend rubber.If a rash develops, discontinue use and consult a physician.
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