While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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(b)(6) 2024: returned product 1 palodent v3 universal ring (green, v5 version) overmodling date codes ¿j¿ for october and ¿o¿ for 2023.This ring observed to have one of tynes on both sides broken as the customer described.There is no batch information provided in this case, therefore no dhr or retain evaluation can be conducted.(nwv).
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