Model Number UPC#681131006712 |
Device Problems
Failure to Obtain Sample (2533); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
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Event Date 03/29/2022 |
Event Type
Injury
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Manufacturer Narrative
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As of 04/22/2022 aso has no received returned samples from consumer or lot info.However, aso reviewed records of biocompatibility tests and latex screening with no issues noted.
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Event Description
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On the initial report received by aso on 03/29/2022 consumer reported that her child had a chemical burn after using the product.Consumer stated that her daughter sought medical attention.She was treated with antibiotics and burn cream.In addition, consumer stated that product caused blisters.
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Search Alerts/Recalls
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