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Catalog Number UNK CUI TISSUE EXPANDER |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Wound Dehiscence (1154); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888)
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Event Type
Injury
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Manufacturer Narrative
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Continued h.6 health effect clinical code: e2327 necrosis.The event of hemorrhage, exposure, and wound dehiscence are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation: hemorrhage, exposure, and wound dehiscence.
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Event Description
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Japanese breast cancer society reported 33 cases of "nipple areolar necrosis", "skin necrosis at the incision site or skin flap", "te exposure from the skin necrosis site", "wound dehiscence", "replaced due to upper deviation of the implant", "pain or discomfort" and "postoperative hemorrhage/hematoma".Devices placement are unknown.This record will represent the 10 nsms devices involved.
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Search Alerts/Recalls
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