Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Udi number, catalog number and device lot numbers are unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
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Event Description
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It was reported that an rn noted that patient's trach had a broken a flange right by trach stoma.Item and lot number unknown.Additional information was requested; however, no further specific details on this incident were received.No patient injury or adverse effects were reported.
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Manufacturer Narrative
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Other text: h6: event problem and evaluation codes: updates not required.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A dhr review was not conducted since no lot number was provided.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.
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Search Alerts/Recalls
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