Catalog Number A281S00200400 |
Device Problem
Break (1069)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Since there has been a previous report received with the same product where this malfunction resulted in a serious injury it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event 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 a heat-carrier plugger 2-4 broke during use.Outcome of this event is unknown as of this mdr.Further information requested.
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Manufacturer Narrative
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Investigation results: no product and no lot# available.No investigation or dhr review can be done.Additional information received: we received the following information regarding this complaint.1.No patient was injured.2.The broken parts were not in the patient's mouth or were removed from there.4.No further treatment, either medical or surgical, was required.5.The instrument was used approx.1x daily before the incident.
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Search Alerts/Recalls
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