Model Number 1031120000 |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problems
Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/30/2019 |
Event Type
Injury
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Event Description
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It was reported that the curved injection needle became stuck in the patient's back.Medical intervention was necessary as it was reported that the physicians had to dissect to the bone and cut off the needle flush at the bone leaving the portion that was stuck in the patient's body.The remainder of the needle was left behind in the patient.No further adverse consequences were reported.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document device evaluation results.
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Event Description
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It was reported that the curved injection needle became stuck in the patient's back.Medical intervention was necessary as it was reported that the physicians had to dissect to the bone and cut off the needle flush at the bone leaving the portion that was stuck in the patient's body.The remainder of the needle was left behind in the patient.No further adverse consequences were reported.
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Event Description
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It was reported that the curved injection needle became stuck in the patient's back.Medical intervention was necessary as it was reported that the physicians had to dissect to the bone and cut off the needle flush at the bone leaving the portion that was stuck in the patient's body.The remainder of the needle was left behind in the patient.No further adverse consequences were reported.
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Manufacturer Narrative
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Correction: b2.This correction is being filed to update outcomes attributed to the adverse event.
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Search Alerts/Recalls
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