|
Catalog Number 1162025 |
Device Problem
Patient-Device Incompatibility (2682)
|
Patient Problem
Wound Dehiscence (1154)
|
Event Date 11/10/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
As reported, post implant of the xenmatrix, the patient was diagnosed with wound dehiscence.The clinician has assessed the patient¿s postoperative course as possibility related to the study device and possibly related to the procedure.However, based on the information provided, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 35 units released for distribution in february, 2015.
|
|
Event Description
|
Alleged per clinical trial dvl-he-020: on (b)(6) 2015, the subject patient underwent first time recurrent incisional suprapubic open hernia repair procedure, during which a xenmatrix surgical graft was trimmed and placed in sublay fashion, fixated using vicryl sutures with interrupted stitch technique.The fascia closure and full skin closure was achieved using sutures.The patient was discharged from the hospital on (b)(6) 2015.Concomitant procedures include panniculectomy, lysis of adhesion(s).On (b)(6) 2015, the subject patient was diagnosed with wound dehiscence.The patient underwent ct scan which shows no hernia recurrence/fluid collections and the ae was resolved on (b)(6)2016.The ae is clinically assessed to be of mild severity, possibly related to the study device and possibly related to the procedure and recovered/resolved.The reported adverse event does not meet the definition of an sae (serious adverse event).
|
|
Search Alerts/Recalls
|
|
|