ALLERGAN SERISCAFFOLD SURGICAL SCAFFOLD (OUS); MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
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Catalog Number SCF10X25AEGEN |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Wound Dehiscence (1154); Cellulitis (1768); Ecchymosis (1818); Edema (1820); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Discharge (2225)
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Event Date 02/28/2014 |
Event Type
Injury
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Event Description
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Physician reported "spotting where the wound is.Later the spotting turned to redness" on (b)(6) 2014.The patient started antibiotics.On (b)(6) 2014, the "wound opened, scaffold's area is red and purple." the physician indicated the "subject may have an allergy." on (b)(6) 2014, physician reported "bilateral redness in lower poles, without fever, restricted to skin overlying both scaffolds." the physician also noted "swelling" in the same area of redness of the breasts.Patient was admitted to the hospital, and had surgery on (b)(6) 2014 where the device was explanted.Fluid cultured was "positive for staphylococcus epidermis.".
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Manufacturer Narrative
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Allergan has received the product, however, the analysis has not been completed at this time.The event of erythema, edema, wound dehiscence, ecchymosis, infection, and allergic reaction are surgical/physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for these events.
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Manufacturer Narrative
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Medwatch sent to fda on 4/27/2016.
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Event Description
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Physician reported "spotting where the wound is.Later the spotting turned to redness" on (b)(6) 2014.The patient started antibiotics.On (b)(6) 2014, the "wound opened, scaffold's area is red and purple".The physician indicated the ¿subject may have an allergy".On (b)(6) 2014, physician reported ¿bilateral redness in lower poles, without fever, restricted to skin overlying both scaffolds".The physician also noted "swelling" in the same area of redness of the breasts.Patient was admitted to the hospital, and had surgery on (b)(6) 2014 where the device was explanted.Fluid cultured was "positive for staphylococcus epidermis".Follow up report from physician indicated the redness and swelling was determined to be cellulitis.Physician also noted "discharge l breast.".
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