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Model Number 1DLMCP02 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
Pain (1994); Not Applicable (3189)
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Event Date 11/04/2011 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿.
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Event Description
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2008 whereby a gore dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2011, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: additional surgery, mesh removal, and abdominal pain.Additional event specific information was not provided.
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Manufacturer Narrative
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Added medical history.Conclusion code remains unchanged.Added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to (b)(6) 2008, including records for repair of inguinal hernia and cholecystectomy were not provided.Operative records dated (b)(6) 2008 indicate the patient underwent exploratory laparotomy, lysis of adhesions and epigastric/ventral hernia repair with mesh placement (gore-tex mesh placement).The patient ¿is a 57-year-old white male who presents with an epigastric/ventral hernia.The patient noticed increasing size and increasing discomfort, easily reducible, but tender on deep palpation.It has gotten a lot bigger, so the above procedures were indicated.¿ the operative records dated (b)(6) 2008 state: ¿patient was marked by me in the holding area before coming to the operating room.His hernia started right at the xiphoid, going all the way down to the umbilicus, and, when he sat up, he had a lot of weakness in his abdominal wall, some deep penetration of the abdomen.¿ the records dated (b)(6) 2008 continue: ¿a midline incision was made after the patient was prepped and draped in a sterile manner, starting from the xiphoid and going all the way down to the umbilicus, going through the skin, fatty tissue, and all the way down to the fascia, and we got down to the fascia, and he did have a weakness and some thinning of the abdominal wall.We were able to go ahead and open up the fascia and get into the abdomen.¿ operative records dated (b)(6) 2008 state: ¿we stayed preperitoneally , taking down some adhesions, freeing it up all the way down.We stayed preperitoneally , and then we did some skin flaps using cautery and getting the flaps all the way out about 3 inches on both sides of the incision.After this was performed, we were able to pull the fascia together nicely.¿ records dated (b)(6) 2008 state: ¿i went in and put a piece of gore-tex mesh after soaking in kantrex saline solution, and then we placed it into the defect, and we anchored it at the superior part of the wound and inferior portion of the wound using the gore-tex suture, and then we did a running, locking closure suture, incorporating the fascia with the mesh, starting on 1 side of the abdomen and then tying to itself in the inferior part, and then going through the other side of the abdomen and tying to the superior part of the suture.¿ operative records dated 1/7/2008 continue: ¿this came together very nicely with minimal amount of tension, and it lay nicely.All sutures were placed with direct vision while placement, so we know we did not injure any bowel or get into any tissues that did not need to be sutured.It came together very nicely and, after it was all tied down, it tightened up real nicely.¿ records dated (b)(6) 2008 state: ¿after this was performed, the wound was then irrigated with kantrex saline solution.The mesh was soaked in kantrex saline solutions before placement, also.The anterior fascia was then approximated using 0-running vicryl and starting from the superior [sic] midline, [sic] and tied in the middle.After this was performed, the wound was then irrigated with kantrex saline solution again, and then the skin flaps were then approximated with 3-0 popoffvicryls, and the skin was closed with staples.A pressure dressing and abdominal binder placed on the patient.¿ the records confirm a gore dualmesh®plus biomaterial (1dlmc02/04848576) was used during the procedure.Surgical follow up chart records dated (b)(6) 2008 state: ¿he is doing great, he is eating, drinking and getting around good.He is healing up nicely.The deep pain he had before surgery is totally gone now.Half of the staples were removed, wound was steri-stripped.¿ surgical follow up chart records dated 1/21/2008 state: ¿he is doing pretty well.I went ahead and asipirated about 150cc of serous fluid from his wound but no signs of infection, no signs of any problem.Staples were removed today, wound was steri stripped.¿ surgical follow up chart records dated (b)(6) 2008 state: ¿he is doing better.He is eating, drinking and getting around better, he has no complaints whatsoever.His is healing up nicely and doing super, it looks like he may have a little fluid underneath the wound, but i am not going to drain it today.¿ surgical follow up chart records dated 2/27/2008 state: ¿healing up nicely and doing great.Continue local wound care.¿ surgical follow up chart records dated 5/28/2008 state: ¿overall, doing well, no complaint, healing up nicely and doing super.¿ surgical follow up chart records dated 6/27/2008 state: ¿he started having a little discomfort in the upper part of his incision and a little bit of fullness and i went ahead and got a cat scan of the abdomen and pelvis, it did not show any kind of recurrence, it did show some mild fluid collection just post op changes nothing major.¿ surgical follow up chart records dated (b)(6) 2008 state: ¿now he says he has developed another hernia.Cat scan on him back in june, it just shows an eventration of the abdomen.He says he is starting to hurt some.I really do not think he needs to have anything done at this time.¿ records between (b)(6) 2008 and (b)(6) 2011 were not provided.History and physical records dated (b)(6) 2011 state: patient ¿is a 60-year-old gentleman referred by dr.(b)(6) for evaluation and possible surgical intervention for recurrent ventral incisional hernia.The patient states that he underwent ventral hernia repair in 2008 or 2007.This sounds as if it was a repair of a diastasis of the rectus musculature.He has undergone an extensive workup which has failed to reveal any obvious causes to his epigastric pain.He notes that over the past several years his pain has worsened and he felt as if his repair was "coming undone" during a coughing spell.¿ records dated (b)(6) 2011 continue, impression: ¿persistent epigastric abdominal pain in a patient who previously underwent repair of a rectus diastasis.Concerns were raised for possible dehiscence of this fascia and recurrence of a true ventral hernia in this case.Clearly i cannot tell this on physical examination.Imaging studies are one option ; however , that would be diagnostic, but not therapeutic.We discussed the potential manner for diagnostic laparoscopy and simultaneous adhesiolysis, possible repair of hernia with placement of mesh.¿ operative records dated (b)(6) 2011 indicate the patient underwent diagnostic laparoscopy with lysis of adhesions.Operative findings state: ¿omentum adherent to anterior abdominal wall.No evidence of ventral hernia.Evidence to support mesh placed in the anterior abdominal wall with dense scarring , but no recurrence.¿ the operative records dated (b)(6) 2011 state: ¿the laparoscope was inserted and the abdomen was surveyed and no injuries were identified.Immediately identified was omentum densely adherent to the anterior abdomina l wall in the previous location of his ventral incisional hernia repair.¿ the records dated (b)(6) 2011 continue: ¿using these 2 ports and electrocautery with shears, the omentum was detached from the anterior abdominal wall.There was effectively no bleeding during this.Inspection yielded no evidence of a recurrent hernia.There was some evidence to support previous ly placed mesh in the abdomen as mesh could be seen through the peritoneal membrane.As there were no further repairs necessary , the pneumoperitoneum was released , both cannulae were removed and the skin incisions closed with subcuticular 4-0 monocryl.Mastisol, steri-strips and sterile dressings were applied.¿ history and physical records dated (b)(6) 2011 state: patient ¿is a 60-year-old gentleman who i originally saw in my office (b)(6) 2011, for abdominal pain.He had previously had a ventral herniorrhaphy (i believe this was actually repair of a rectus diastasis) with placement of mesh.He developed postoperative abdominal pain, for which i performed diagnostic laparoscopy with lysis of adhesions on 10/07/2011.¿ the records dated (b)(6) 2001 continued: ¿he returned to my office postop 10/27/2011 , with no trouble , relief of most of his symptoms; however , continues to have persistent abdominal pa in and a "pulling sensation" across the upper abdomen.I did identify the previously placed mesh in the upper abdomen , but this was extraperitoneal.I highly suspect that this mesh is causing his ongoing discomfort.When mr.Hugues was in my office 10/27/2011 , he expressed a desire to have this mesh removed and either replaced with a softer form of mesh or not at all, depending on assessment of any existing hernia.¿ operative records dated (b)(6) 2011 indicate the patient underwent abdominal wall exploration with explantation of previously placed mesh and repair of resultant ventral hernia.The patient ¿is a 60-year-old gentleman with a previous "repair" of a rectus diastasis in alabama several years ago with placement of dualmesh.He has had persistent abdominal pain.He did undergo diagnostic laparoscopy with adhesiolysis with relief of some of this pain; however, he complains of bilateral pulling sensation in the upper abdomen consistent with mesh retract ion.He was offered watchful waiting versus explantation of mesh.He stated that he had waited long enough and was anxious to have this mesh removed.¿ records dated (b)(6) 2011 state: ¿the operation commenced by incising the skin along his previous incision in the upper midline.Subcutaneous tissue was divided with electrocautery.Dense inflammatory changes were noted in the subcutaneous tissue and some of the scar and cicatrix was excised with electrocautery.The anterior fascia was easily noted and was divided, revealing the previously placed davol dualmesh.The mesh was excised circumferentially using electrocautery to divide attachments and scissors to divide gore-tex sutures.Once the mesh had been completely explanted it was passed off the operative field.¿ the operative records dated (b)(6) 2011 continue: ¿i did not see any rationale for subjecting it to pathologic examination.At this point , the resultant hernia defect was reapproximated in a primary fashion using a running #1 pds followed by additional suture in a figure-of-eight 0 pds to buttress the wound.A #7 flat jackson-pratt drain was placed into the wound bed and brought out through separate stab wound incision.This drain was secured to the skin using 2-0 silk.The wound was irrigated with sterile saline solution and aspirated.At this point , the wound was closed in layers using 3-0 vicryl for subcutaneous tissue and 4-0 monocryl for skin.Mastisol, steri-strips and sterile dressings were placed.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated result code.Conclusion code remains unchanged.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to 07/18/2007, including records for repair of inguinal hernia and cholecystectomy were not provided.On (b)(6) 2007: (b)(6), md.Office notes.Works at (b)(6) in or.Epigastric hernia, there for a while, has gotten bigger, has been bothering him about five years.Easily reducible.Discussed operation, complications, risks of surgery, understands fully.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the instructions for gore® dualmesh® plus biomaterial use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records for repair of inguinal hernia and cholecystectomy were not provided.(b)(6) 2008: [missing records: operative report and implant record for implantation of alleged gore device not provided.] product identification records for the alleged gore device were not provided.(b)(6) 2008: (b)(6).Radiology-ct abdomen/pelvis.Impression: mild fluid collection in the subcutaneous tissues of the anterior abdominal wall, likely related to previous surgery.The liver is diffusely decreased in density consistent with fatty infiltration.There is a focus of slightly increased density in the region of the gallbladder fossa as described above.This could represent an area of focal fatty sparing.Diverticulosis.Postsurgical changes in the left inguinal region and possibly in the rectum.Clinical correlation is recommended.Records between (b)(6) 2008 and (b)(6) 2011 were not provided.(b)(6) 2011: (b)(6) medical center.(b)(6) md.History and physical.Chief complaint: epigastric abdominal pain.Referred by dr.Charles davis for evaluation of surgical intervention for recurrent ventral incisional hernia.States underwent ventral hernia repair in 2008 or 2007.Sounds as if repair of diastasis of rectus musculature.Undergone extensive workup which failed to reveal any obvious causes to epigastric pain.Over past several years pain has worsened and felt as if repair ¿coming undone¿ during coughing spell.Seen in consultation (b)(6) 2011.This history and physical reflects date of consultation.Review of symptoms: positive for some dysphagia, heartburn, abdominal pain with nausea and blood per rectum.Exam: mild tenderness in epigastric region on deep palpation.Persistent evidence of diastasis of rectus musculature.Do not feel discrete hernial deficit.Impression: persistent epigastric abdominal pain in patient who previously underwent repair of rectus diastasis.Concerns raised for possible dehiscence of fascia and recurrence of true ventral hernia.Discussed potential manner for diagnostic laparoscopy and simultaneous adhesiolysis, possible repair of hernia with placement of mesh.Does wish to proceed.Preoperative orders completed.(b)(6) 2011: [missing records: a pathology report detailing analysis of the device removed during the (b)(6) 2011: procedure was not provided.] (b)(6) 2011:(b)(6) medical center [assigned].(b)(6) md.Office notes.Underwent exploration of abdominal wall with removal of previously placed abdominal wall mesh by an outside surgeon.Occurred (b)(6) 2011.Drain placed, now minimal amounts fluid over 24 hours.Anxious to have drain removed.No postoperative complications or concerns.Exam: abdominal wall soft, mildly tender at incision.Incision clean and dry.Steri-strips intact.No surrounding erythema or drainage.Drain, appropriate resolution of output.Removed.2x2 gauze with band-aid.Impression: status post explantation previously placed hernia mesh with subsequent primary herniorrhaphy.Doing very well.No postoperative concerns or complaints.Antecedent symptoms of pain largely resolved, reserving final judgement for next several weeks.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ w.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Previous patient code (1994) was reported based on the original complaint and are no longer applicable per gore¿s investigation.The investigation has been completed.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.The following information was determined from the medical records.Medical records: the known medical records span july 18, 2007 through november 10, 2011, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial.Records from september 10, 2008 through september 4, 2011 were not provided.Patient information: medical history: hypertension, degenerative disc disease, chronic neck pain.Prior surgical procedures: [dates unknown] carpal tunnel release, hemorrhoidectomy, ventral hernia repair, vasectomy, cholecystectomy.Implant preoperative complaints: on (b)(6)2007: ¿epigastric hernia, there for a while, has gotten bigger, has been bothering him about five years.Easily reducible.Discussed operation, complications, risks of surgery, understands fully.¿ implant procedure: exploratory laparotomy, lysis of adhesions and epigastric/ventral hernia repair with mesh placement.Implant: gore® dualmesh® plus biomaterial (04848576/1dlmcp02) 8cm x 12cm.Implant date: (b)(6) 2008.Description of hernia being treated: ¿his hernia started right at the xiphoid, going all the way down to the umbilicus, and, when he sat up, he had a lot of weakness in his abdominal wall, some deep penetration of the abdomen.A midline incision was made after the patient was prepped and draped in a sterile manner, starting from the xiphoid and going all the way down to the umbilicus, going through the skin, fatty tissue, and all the way down to the fascia, and we got down to the fascia, and he did have a weakness and some thinning of the abdominal wall.We were able to go ahead and open up the fascia and get into the abdomen.We stayed preperitoneally, taking down some adhesions, freeing it up all the way down.We stayed preperitoneally, and then we did some skin flaps using cautery and getting the flaps all the way out about 3 inches on both sides of the incision.¿ implant size and fixation: ¿after this was performed, we were able to pull the fascia together nicely.I went in and put a piece of gore-tex mesh after soaking in kantrex saline solution, and then we placed it into the defect, and we anchored it at the superior part of the wound and inferior portion of the wound using the gore-tex suture, and then we did a running, locking closure suture, incorporating the fascia with the mesh, starting on 1 side of the abdomen and then tying to itself in the inferior part, and then going through the other side of the abdomen and tying to the superior part of the suture.This came together very nicely with minimal amount of tension, and it lay nicely.All sutures were placed with direct vision while placement, so we know we did not injure any bowel or get into any tissues that did not need to be sutured.It came together very nicely and, after it was all tied down, it tightened up real nicely.¿ post-operative period: [one month] on (b)(6)2008: ¿he is doing great, he is eating, drinking and getting around good.He is healing up nicely.The deep pain he had before surgery is totally gone now.Half of the staples were removed, wound was steri-stripped.¿ on (b)(6)2008: ¿doing pretty well.I aspirated about 150 cc serous fluid from wound, no signs infection.¿ on (b)(6)2008: ¿healing up nicely, doing super.Looks like he may have a little fluid underneath wound, but i am not going to drain it today.¿ relevant medical information: on (b)(6)2008: ct abdomen/pelvis: ¿mild fluid collection in the subcutaneous tissues of the anterior abdominal wall, likely related to previous surgery.¿ on (b)(6)2008: ¿having little discomfort in upper part of incision.Cat scan did not show any kind of recurrent, did show some mild fluid collection just post op changes nothing major.¿ on (b)(6)2008: ¿now he says he has developed another hernia.Cat scan on him back in june, it just shows an eventration of the abdomen.He says he is starting to hurt some.I really do not think he needs to have anything done at this time.¿ on (b)(6)2011: ¿evaluation and possible surgical intervention for recurrent ventral incisional hernia.The patient states that he underwent ventral hernia repair in 2008 or 2007.This sounds as if it was a repair of a diastasis of the rectus musculature.He has undergone an extensive workup which has failed to reveal any obvious causes to his epigastric pain.He notes that over the past several years his pain has worsened and he felt as if his repair was ¿coming undone¿ during a coughing spell.¿ on (b)(6)2011: diagnostic laparoscopy with lysis of adhesions. ¿omentum adherent to anterior abdominal wall.No evidence of ventral hernia.Evidence to support mesh placed in the anterior abdominal wall with dense scarring, but no recurrence.¿ explant preoperative complaints: on (b)(6)2011: ¿he had previously had a ventral herniorrhaphy (i believe this was actually repair of a rectus diastasis) with placement of mesh.He developed postoperative abdominal pain, for which i performed diagnostic laparoscopy with lysis of adhesions on (b)(6)2011.He returned to my office postop (b)(6)2011, with no trouble, relief of most of his symptoms; however, continues to have persistent abdominal pain and a ¿pulling sensation¿ across the upper abdomen.I did identify the previously placed mesh in the upper abdomen, but this was extraperitoneal.When [the patient] was in my office (b)(6)2011, he expressed a desire to have this mesh removed and either replaced with a softer form of mesh or not at all, depending on assessment of any existing hernia.¿ explant procedure: abdominal wall exploration with explantation of previously placed mesh and repair of resultant ventral hernia.Explant date: (b)(6) 2011.¿the operation commenced by incising the skin along his previous incision in the upper midline.Subcutaneous tissue was divided with electrocautery.Dense inflammatory changes were noted in the subcutaneous tissue and some of the scar and cicatrix was excised with electrocautery.The anterior fascia was easily noted and was divided, revealing the previously placed davol [sic] dualmesh.The mesh was excised circumferentially using electrocautery to divide attachments and scissors to divide gore-tex sutures.Once the mesh had been completely explanted it was passed off the operative field.I did not see any rationale for subjecting it to pathologic examination.At this point, the resultant hernia defect was reapproximated in a primary fashion using a running #1 pds followed by additional suture in a figure-of-eight 0 pds to buttress the wound.¿ relevant medical information: on (b)(6)2011: ¿status post explantation previously placed hernia mesh with subsequent primary herniorrhaphy.Doing very well.No postoperative concerns or complaints.Antecedent symptoms of pain largely resolved, reserving final judgement for next several weeks.¿ conclusion: it should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ the gore® dualmesh® plus biomaterial instructions for use warns, ¿improper positioning of the smooth, non-textured surface adjacent to fascial or subcutaneous tissue will result in minimal tissue attachment.Persistent seroma may result.¿ individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.All available information has been placed on file for use in product surveillance, tracking, trending and follow-up.Section c1: name: plus antimicrobial product coating.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 04848576.Additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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