Model Number UPC#681131006729 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Blister (4537)
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Event Date 01/10/2023 |
Event Type
Injury
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Manufacturer Narrative
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As of 01/30/2023 returned product and retained samples were submitted to the lab with no defects noted.In addition, aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.
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Event Description
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The consumer stated on (b)(6) 2022 that product caused his skin to blister where the adhesive was on his skin.Consumer returned customer information request (cir) on (b)(6) 2023.The consumer reported using the product on his knee to cover a scrape.The consumer stated that the symptoms were corrected after stopping using the product.In addition, the consumer confirmed that the issue was with the tape area.
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Search Alerts/Recalls
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