Model Number UPC#681131006729 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Skin Burning Sensation (4540)
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Event Date 09/20/2022 |
Event Type
Injury
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Manufacturer Narrative
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As of 10/11/2022 aso submitted unused returned product and retained samples for testing with no defects observed.Aso reviewed records of satisfactory biocompatibility tests for this type of product with no issues noted.In addition, complaint database was reviewed and no negative trend has been identified for the associated product.Refer to this report for further details.
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Event Description
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Consumer stated on (b)(6) 2022 that product caused a burn.Consumer returned customer information request (cir) on (b)(6) 2022.Consumer informed that the product left a chemical burn and the issue was with the tape area.Consumer stated that he required medical attention and that the symptoms corrected after he stopped using the product.
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Search Alerts/Recalls
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