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Catalog Number 1161928 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Wound Dehiscence (1154); Seroma (2069)
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Event Date 12/31/2014 |
Event Type
Injury
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Manufacturer Narrative
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As reported, post implant of the xenmatrix graft, the patient was diagnosed with superficial wound dehiscence and subsequent seroma.The clinician has assessed the patient¿s postoperative course as definitely related to the study device, and possibly related to the procedure.However, based on the information provided, no conclusion can be made.Review of the manufacturing records shows the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june 2014.Seroma is a known inherent risk of surgery and is listed as a possible complication in the instructions- for-use supplied with the device.The information provided by bd 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 bd.Not returned - remains implanted.
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Event Description
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Alleged per clinical trial (b)(4): on (b)(6) 2014, the patient underwent multiple recurrent ventral midline open hernia repair procedure during which a xenmatrix surgical graft was trimmed and placed in underlay fashion, fixated using maxon sutures.Fascia was completely closed using maxon suture through interrupted stitch and full skin closure was achieved using sutures.Concomitant procedure included panniculectomy and lysis of adhesion(s).The patient was discharged home on (b)(6) 2014.On (b)(6) 2014, the patient was diagnosed with superficial wound dehiscence which resolved on (b)(6) 2015.The ae (wound dehiscence) is clinically assessed to be of mild severity, definitely related to the study device, possibly related to the procedure and recovered/resolved.The reported adverse event does not meet the definition of an sae (serious adverse event).On (b)(6) 2015, the patient was diagnosed with seroma and hospitalized on (b)(6) 2015.On (b)(6)2015 patient underwent a surgery for the seroma.Fascia was completely closed using vicryl suture through interrupted stitch and full skin closure was achieved.The patient was discharged home the same day.The ae (seroma) is clinically assessed to be of moderate severity, definitely related to the study device, possibly related to the procedure and recovered/resolved.The reported adverse event meets the definition of an sae (serious adverse event) and does not meet the uade (unanticipated adverse device effects).
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Search Alerts/Recalls
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