Catalog Number EL-001 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Event Description
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Healthcare professional reported "the doctor has detached the letters of the insertion sleeve, and it has caused contamination of the field and the implant." device was hydrated using betadine.The device was in contact with the patient's skin."the surgery was completed by washing the inside of the breast pocket profusely to remove the remaining blue lettering and continued as a normal augmentation without using the sleeve.".
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Manufacturer Narrative
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Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: there was no reoperation as surgery was completed with a backup breast implant.
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Event Description
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Healthcare professional reported "the doctor has detached the letters of the insertion sleeve, and it has caused contamination of the field and the implant." device was hydrated using betadine.The device was in contact with the patient's skin."the surgery was completed by washing the inside of the breast pocket profusely to remove the remaining blue lettering and continued as a normal augmentation without using the sleeve.".
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Manufacturer Narrative
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Additional, changed, and/or corrected data: d1, d4.
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Event Description
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Healthcare professional reported "the doctor has detached the letters of the insertion sleeve, and it has caused contamination of the field and the implant." device was hydrated using betadine.The device was in contact with the patient's skin."the surgery was completed by washing the inside of the breast pocket profusely to remove the remaining blue lettering and continued as a normal augmentation without using the sleeve.".
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Manufacturer Narrative
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Additional, changed, and/or corrected data: h6.
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Search Alerts/Recalls
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