Device Problem
Reaction (1514)
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Patient Problems
Burn(s) (1757); Surgical procedure (2357); Reaction (2414); Treatment with medication(s) (2571)
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Event Date 06/20/2014 |
Event Type
Injury
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Manufacturer Narrative
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It was reported that the patient underwent a breast biopsy on (b)(6) 2014 for a bird 4 finding on mammogram and a topical skin adhesive was used.The patient immediately started to experience burning.The wound never closed and she underwent debridement on (b)(6) 2014.She required percocet & dilaudid for the pain.She was diagnosed by a physician with 2nd and 3rd degree burns on (b)(6) 2014.The wound has since healed.She stated that the plastic surgeon has suggested possible scar excision surgery.
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Manufacturer Narrative
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This medwatch report is associated to maude event report mw 5037261.
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Event Description
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It was reported by the patient that she underwent a breast biopsy on (b)(6) 2014 and a topical skin adhesive was used to close the incision.She developed ¿burns¿ at the site of application.She underwent wound debridement for 7 days and was treated with silvadene.The wound was negative for bacteria.She is scheduled for a plastic surgery consult for treatment of the open wound.Additional information has been requested.
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Manufacturer Narrative
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(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
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Search Alerts/Recalls
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