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Catalog Number 659760V |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2024 |
Event Type
malfunction
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Manufacturer Narrative
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While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr 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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Event Description
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In this event it is reported that palodent v3 univ 2 ring refil broke during use.
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Manufacturer Narrative
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Failure mode: broken product.Root cause: no defect proven.Conclusion code: no failure found.6-4-2024: dhr for item# (b)(4) batch# 06616069 has been pulled, reviewed, and attached to this case.Dhr review did not indicate any production issues while packaging/labeling the palodent v3 univ 2 ring refill.Work order (b)(4) is the packaging work order which utilized over-molding of the springs to rings production work order/run for item# (b)(4) (v5 ring universal - palodent) batch# 06603963 (produced 04-2023).Dhr for item# (b)(4) batch# 06603963 has also been pulled, reviewed, and attached to this case.Dhr review did not identify any issues during production, with all inspections performed and deemed acceptable by the operator(s) and quality as per 0290-wi-7.5-60-14 & 0290-ip-7.5-60-58.(nwv).6-4-2024: final product retains are not kept as per normal procedure.Retains from overmolding item# (b)(4) batch# 06603963 were reviewed and inspected per 0290-ip-7.5-60-58 and were found acceptable.(nwv).
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Search Alerts/Recalls
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