Catalog Number CM1097 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Seroma (2069)
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Event Date 10/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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Conclusion: this event is being reported for the medical intervention to treat the late onset infected seroma.The device remains implanted and has not been returned for evaluation.Lot number information was received on 03/jan/2019; therefore a review of the device history records for lot up100096 is on-going.Findings will be submitted in a follow up adverse event report.
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Event Description
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It was reported that a patient underwent a bilateral pre-pectoral breast reconstruction with artia (l: (b)(4)) on (b)(6) 2017.On (b)(6) 2018, patient underwent bilateral exchange for implants and the artia appeared fine intraoperatively.In mid-(b)(6) 2018, the patient developed left side red breast and late onset infected seroma.Patient was placed on antibiotics and drain placed for 4 weeks and has resolved.Cultures of seroma fluid were negative.The artia devices are still in place.This complaint is associated with the second of 2 devices implanted on the left side in this patient.Refer to medwatch 1000306051-2018-00159 for the first device implanted in this patient.
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Event Description
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This is a follow up #1 to provide device history record review for lot up100096 completed on 14/jan/2019 and investigation conclusion.As reported in the initial: it was reported that a patient underwent a bilateral pre-pectoral breast reconstruction with artia (l: up100097-026, up100096-024; r: up100097-025, up100096-023) on 14/oct/2017.On 12/apr/18, patient underwent bilateral exchange for implants and the artia appeared fine intraoperatively.In mid-october 2018, the patient developed left side red breast and late onset infected seroma.Patient was placed on antibiotics and drain placed for 4 weeks and has resolved.Cultures of seroma fluid were negative.The artia devices are still in place.This complaint is associated with the second of 2 devices implanted on the left side in this patient.Refer to medwatch 1000306051-2018-00159 for the first device implanted in this patient.
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Manufacturer Narrative
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Qa investigation into lot up100096 resulted in no remarkable findings including 39 devices distributed with no other complaints against the lot and no related deviations or nonconformances revealed during processing.Lot up100096 was terminally sterilized within the process parameters and met all qc release criteria.Based on the results of the investigation, a relationship between the artia and this event could not be determined.It should be noted that the artia device remains implanted and that lot up100096 was also implanted in the right breast with no complications.No further actions are required at this time, as a nonconformance could not be confirmed.
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Search Alerts/Recalls
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