Model Number DX113 |
Device Problem
Component Incompatible (1108)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation results: the components were examined visually.The products with the reference code dx113 are made completely out of silicone.They do not have a drilling made of metal, and therefore they do not have a gap where the residues remain.The product does not require batch management; a review of the device quality and manufacturing history records is not possible.No failure could be detected.The mentioned failure cannot occur on dx113.An internal inspection was initiated ((b)(4)).
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Event Description
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It was reported that there was an issue with a oral silicone wedge.According to the customer it was reported that the product cannot be cleaned properly.During a routine check the customer found residues between the metal insert and the silicone (protein test was positive).There was no patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00176 ((b)(4) dx115).
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Manufacturer Narrative
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Additional case created.See b5.
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Event Description
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Additional product with the notification number 400470331 was created.Awareness date is 04.28.2020.Associated medwatch report.9610612-2020-00175 (400472614 dx113).9610612-2020-00176 (400472615 dx115).
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Manufacturer Narrative
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After a closer examination of the article and the risk of the article, it was found that the article in this size and design does not have a screw in the appropriate and claimed place.Therefore, the error pattern cannot occur with this article.Due to clarification, the report was reassessed and found to no longer require submission - no malfunction or serious injury.
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Search Alerts/Recalls
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