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Catalog Number 1161935 |
Device Problem
Material Disintegration (1177)
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Patient Problem
Unspecified Infection (1930)
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Event Date 06/15/2013 |
Event Type
Injury
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Manufacturer Narrative
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A manufacturing review that included review of sterility records was performed and found that the lot was manufactured / sterilized to specification.The ifu for the xenmatrix graft was reviewed and states, "place device in maximum possible contact with healthy, well vascularized tissue to promote cell ingrowth and tissue remodeling." and "if an infection develops, it should be treated aggressively.¿ post surgical staph infection is a known inherent risk of any surgical procedure.Additionally, the investigation performed confirms that the graft provided was sterilized per procedure prior to distribution.Based on the events as reported, a definitive conclusion cannot be made at this time.Should additional information be provided, a supplemental mdr will be submitted.Note: the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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The following was reported to davol and included the implant operative report: on (b)(6) 2013- the patient underwent an open ventral hernia repair, laparoscopic component separation, bilateral implant of mesh, skin flap resection and plastic surgery closure.The patients defect is noted to be 22cm wide x 30cm in length.A previously implanted, mesh was explanted at this time.A component separation was performed to allow closure of the midline defect; the bard xenmatrix graft was placed in the rectorectus fashion and trimmed as needed.The operative dictation also notes that "a small tear in the right side of the rectus sheath was repaired using a leftover piece of xenmatrix, which was tacked as an onlay into this area." three french jp drains were placed at the end of the procedure.The following is additional information provided by the contact and is not based on patient medical records: on (b)(6) 2013 - it is alleged the patient developed a staph infection, that was life threatening and clinically significant.On (b)(6) 2013 - it is alleged the patient underwent two wound cleaning procedures, during which 25lbs of material was removed.As reported the xenmatrix graft had been eaten away by the infection.However, some pieces may have been removed during wound cleaning.It is reported that radiologist stated that the graft is no longer present in the body.
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Search Alerts/Recalls
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