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Model Number 0010303 |
Device Problems
Defective Device (2588); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240); Disability (2371)
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Event Date 03/09/2015 |
Event Type
Injury
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Manufacturer Narrative
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Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the information provided, it is alleged the patient experienced hernia recurrence and adhesions.Both recurrence and adhesions are known inherent risks of hernia repair surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complication.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.This file represents the ventralex (device #2) implanted in (b)(6) 2010.A second emdr has been submitted to address the other ventralex mesh (device #1) implanted in (b)(6) 2010.Not returned to manufacturer.
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Event Description
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The following was reported to davol by the patient's attorney: (b)(6) 2010 - the patient underwent surgery for repair of a ventral hernia, a bard ventralex mesh, (b)(4) and lot number hutl0021 (device #1) was implanted to repair the hernia defect.(b)(6) 2010 - the patient underwent an additional surgery to repair the recurrent hernia defect and take down adhesions that had formed.A ventralex mesh, (b)(4) and lot number huub0353 (device #2) was implanted to repair the hernia defect.(b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect, take down adhesions, and remove portions of the old mesh.During this procedure a sepramesh was implanted.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.
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Manufacturer Narrative
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Currently, it is unknown to what extent the device may have caused or contributed to the reported event.Based on the information provided, it is alleged the patient experienced hernia recurrence and adhesions.Both recurrence and adhesions are known inherent risks of hernia repair surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complication.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.This file represents the ventralex (device #2) implanted in (b)(6) 2010.A second emdr has been submitted to address the other ventralex mesh (device #1) implanted in (b)(6) 2010.Addendum: this supplemental mdr is submitted to document additional information provided.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per the medical records review, post implant of the ventralex, patient had abdominal pain, adhesions, hernia recurrence; underwent mesh removal and was implanted with sepramesh.Review of manufacturing records confirms product was manufactured to specification.Updated fields: a2, a4, b5, b6, b7, d1, e3, g1, g6, h2, h3, h6, h7, h10 this supplemental emdr is submitted to represent ventralex mesh (device #2).An additional supplemental emdr is submitted to represent ventralex mesh (device #1)¿ 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.H3 other text : not returned.
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Event Description
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The following was reported to davol by the patient's attorney: (b)(6) 2010 - the patient underwent surgery for repair of a ventral hernia, a bard ventralex mesh, reference number (b)(4) and lot number hutl0021 (device #1) was implanted to repair the hernia defect.(b)(6) 2010 - the patient underwent an additional surgery to repair the recurrent hernia defect and take down adhesions that had formed.A ventralex mesh, reference number 0010303 and lot number huub0353 (device #2) was implanted to repair the hernia defect.(b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect, take down adhesions, and remove portions of the old mesh.During this procedure a sepramesh was implanted.The attorney alleges the patient has suffered and will continue to suffer pain and was injured severely and permanently.Addendum per additional information provided: (b)(6) 2010 - patient was diagnosed with incisional hernia following colectomy and underwent open repair with implant of ventralex mesh.Per operative notes, "hernia sac was identified and dissected, then 6.4 cm ventralex patch was inserted below the fascia in the preperitoneal space with the ptfe side posteriorly to cover the defect, with a couple of centimeter overlay.The tails of the patch were attached to the fascial edges and trimmed & sutured".(b)(6) 2010 - patient was diagnosed with recurrent incisional hernia and underwent revision surgery with implant of a new ventralex mesh.Per operative notes, "fascial defect was identified & dissected, there were adhesions towards the midline where the previous mesh was placed & were taken down, then 8 cm ventralex mesh was inserted with ptfe side posteriorly.The tails of the patch were attached to the adjacent fascia with sutures and trimmed." (b)(6) 2011 - patient was admitted for abdominal pain due to ventral hernia.(b)(6) 2015 - patient was underwent old mesh removal and implant of sepramesh ip.Per operative notes, "the fascia was entered cephalad to the supraumbilical defect; there were significant adhesions tethering loops of small bowel & the omentum to a previous mesh and were dissected.Portions if the abdominal wall were resected with explantation of the old mesh.The defect measured approximately 8 cm x 6 cm; a 20 x 10 cm sepramesh ip was delivered onto the field, manicured to fit & sutured".Attorney alleges that the patient experienced adhesions, emotional injuries, mesh migration, mesh shrinkage, nerve damage, pain and recurrence.
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