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Model Number SMEC10C |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Itching Sensation (1943)
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Event Date 11/07/2017 |
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 post breast tissue marker placement through hard tissue, the patient allegedly experienced total body itching.Reportedly, the physician is planning to remove the device.The patient status is unknown.
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Manufacturer Narrative
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Manufacturing review: a complete manufacturing review could not be conducted as the lot number was not provided.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate investigation summary: no sample was returned for evaluation; therefore, the investigation is inconclusive for the allegedly patient-device incompatibility.The definitive root cause could not be determined based upon the available information.
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Event Description
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It was reported that post breast tissue marker placement through hard tissue, the patient allegedly experienced total body itching.The device was removed approximately 2 years 4 months post implantation and the patient was given antihistamines.The patient status is unknown.
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Search Alerts/Recalls
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