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Catalog Number 1161520 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907)
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Event Date 01/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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Based on the information provided, no conclusion can be made.As reported, one month post implant of the xenmatrix graft, the patient presented with a pus pocket behind the graft and underwent explant.There were no signs of infection and as reported, the surgeon suspects the patient had a reaction to the graft.Allergic reaction is identified as a potential complication in the adverse reaction section of the instructions-for-use, supplied with the device.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot (b)(4) released for distribution in april, 2021.Note, the date of explant is estimated as on (b)(6) 2022, based on the information available.
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Event Description
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As reported, during a colostomy reversal procedure on (b)(6) 2021, a bard/davol xenmatrix graft (porcine) was implanted in the patient.It was reported that one month post implant, on (b)(6) 2022, the patient presented with a pus pocket behind the graft.As reported, the pocket was cultured, it was sterile pus and the graft was explanted.As reported, the surgeon indicated that the patient did not have any infection since the culture was negative.As reported, the surgeon felt that the patient had some type of reaction to the xenmatrix graft (porcine).
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Search Alerts/Recalls
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