Model Number 989803137631 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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Serial number not provided.A follow-up report will be submitted once the investigation is complete.We are considering this to be a serious injury,.A request for more information has been made.The customer noted that the product is not available for evaluation.
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Event Description
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The customer stated that a metal piece was left on the babies scalp.
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Manufacturer Narrative
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No product will be returned as it was disposed of after it was used.The reported issue was not found and reported until 3 months after the product was used.The customer stated the patient's mother saw the metal piece on the baby¿s scalp and hence informed us and took the baby to the children¿s hospital.The metal piece was removed and the baby was prescribed an antibiotic.The customer has no further information on the baby.The instructions for use (ifu) state to inspect the spiral tip to ensure that it is still attached to the fse hub.If the tip has separated from the hub and remains embedded in the presenting part, remove it using aseptic technique.The ifu also states "warning: do not over-rotate".Because the instructions for use include clear directions on how to avoid tip breakage and what to do if it occurs, philips sent a communication to users to remind them of these important directions.No further investigation or action is warranted.
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Search Alerts/Recalls
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