Catalog Number UNK GEL MARK ULTRA |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Swelling (2091)
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Event Date 11/23/2018 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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Event Description
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It was reported that approximately seven weeks post breast tissue marker placement, the patient allegedly experienced swelling at the level of the marker.It was further reported the patient required additional intervention.The current patient status is unknown.
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Manufacturer Narrative
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As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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Event Description
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It was reported that approximately seven months post breast tissue marker placement, the patient allegedly experienced swelling at the level of the biopsy area due to an alleged foreign body felt at the site.It was further reported the patient required additional intervention, allegedly removing the foreign body at the biopsy area.The current patient status is unknown.
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Search Alerts/Recalls
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