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Catalog Number 1162025 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Abscess (1690)
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Event Date 01/29/2015 |
Event Type
Injury
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Event Description
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Alleged per clinical trial (b)(6): on (b)(6) 2014, the patient underwent first time recurrent incisional midline open hernia (20 cm x 8 cm) repair procedure, during which a xenmatrix surgical graft was trimmed and placed in inlay fashion intra-peritoneally using anterior component separation technique (cst) method, fixated using sutures.Fascia was achieved using vicryl interrupted sutures and full skin closure was achieved using sutures.Concomitant procedure includes panniculectomy, lysis of adhesions and bowel resection.The patient was discharged to home on (b)(6) 2014.On (b)(6) 2015, the patient was diagnosed with an abscess and was admitted into the hospital.The patient was discharged the next day on (b)(6) 2015.The adverse event was resolved on (b)(6) 2015.The ae is clinically assessed to be possibly related to the study device and not related to the procedure.This has been assessed as a serious adverse event of moderate severity.The reported adverse event meets the definition of an sae (serious adverse event) and does not meet the definition of uade (unidentified adverse device event).
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Manufacturer Narrative
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As reported, about 10 months post-implant, the patient was diagnosed with abscess and was hospitalized.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and not 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 for this manufacturing lot of (b)(4) units released for distribution in january, 2014.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 dvl-he-020: on (b)(6) 2014, the patient underwent first time recurrent incisional midline open hernia (20 cm x 8 cm) repair procedure, during which a xenmatrix surgical graft was trimmed and placed in inlay fashion intra-peritoneally using anterior component separation technique (cst) method, fixated using sutures.Fascia was achieved using vicryl interrupted sutures and full skin closure was achieved using sutures.Concomitant procedure includes panniculectomy, lysis of adhesions and bowel resection.The patient was discharged to home on (b)(6) 2014.On 29-jan-2015, the patient was diagnosed with an abscess and was admitted into the hospital.The patient was discharged the next day on (b)(6) 2015.The adverse event was resolved on 22-apr-2015.The ae is clinically assessed to be possibly related to the study device and not related to the procedure.This has been assessed as a serious adverse event of moderate severity.The reported adverse event meets the definition of an sae (serious adverse event) and does not meet the definition of uade (unidentified adverse device event).
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Manufacturer Narrative
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As reported, about 10 months post-implant, the patient was diagnosed with abscess and was hospitalized.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and not 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 for this manufacturing lot of 33 units released for distribution in january, 2014.Addendum: h11: this is an addendum to the previously submitted mdr to correct unique identifier (udi) # & pma / 510(k) # and to update imdrf b code.Corrected fields: g4 (pma/510(k) #), d.4 (unique identifier (udi) #).Note: section a through f - 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.
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Search Alerts/Recalls
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