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The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/)].Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: on (b)(6) 1994: (b)(6) hospital.Dr.(b)(6).History & physical.Chief complaint: incision (ventral) hernia.History of present illness: ¿this is a, short and obese female who was sent by the (b)(6) center to the office on (b)(6) 1994 because of persistent pain above the naval for the last four months.She initially noted a swelling on that area three months ago.Swelling has gotten bigger and now is accompanies by pain.She has had more problems, especially in the last three weeks.She denies any upper symptoms.Examination showed an incarcerated 4 x 4 cm incisional hernia.She was advised that this will need repair, most likely with the use of mesh.Past personal history: she had an exploratory laparotomy in 1985 because of persistent vomiting.She was found to have intestinal obstruction then secondary to adhesions.In addition, she had an appendectomy.She also had partial hysterectomy.In 1993, she had an exploratory laparotomy for persistent right upper quadrant pain.She was found to have an acute and chronic calculus cholecystitis.There was also an incarcerated umbilical incisional hernia with incarcerated omentum.This was repaired after resection of incarcerated omentum, but mesh was not used.Physical examination: this is a short, obese female in some abdominal distress.Abdomen: there is a large amount of adipose tissue.There is a 4 x 4 cm hernia above the navel, at the lower most part of the incision with evidence of an incarcerated tissue, most likely a preperitoneal fat.There are active bowel sounds without any evidence of obstruction.There is no deep tissue pressure tenderness and there are no intraoral masses that could be palpated.Impression: incarcerated incisional (ventral) hernia.¿ on (b)(6) 1994: (b)(6) hospital.Md.(b)(6).Operative report.Preoperative and postoperative diagnosis: 1.Large ventral (incisional) hernia.2.Chronic obstructive pulmonary disease.3.Marked obesity (pickwickian syndrome).Operation: repair of large ventral incisional hernia using (b)(6) mesh, after reduction of incarceration.Implant: (b)(6).Anesthesia: general.Procedure: ¿under satisfactory general anesthesia, the patient¿s abdomen was prepped and in the usual manner.Examination in the supine and standing position, showed a large incarcerated ventral hernia, immediately above the navel, measuring 10 x 12 cm.It seems from examination that her hernial opening is localized two approximately 1 ½ inches above the navel.To facilitate postoperative care and minimize pain, a transverse incision was made centering on the prominent part of the hernia.The incision was deepened into the subcutaneous tissue and down to the hernial sac.The hernial sac was separated from the surrounding subcutaneous tissue and traced down to the facial level.The actual opening of the large ventral hernia measured 6 x 6 cm.However, after excising the incarcerated omentum and the hernial sac and opening the peritoneal cavity, examination above and below the previous midline incision showed several smaller hernias.These other hernias were then joined with the big hernia to facilitate closure.After being sure that there were no adhesions and a problem with the small and large bowel, the facial margins were initially repaired withinterrupted #1 nurolon.The remaining opening in the center measured 7 x 7 cm.This opening could not be closed without creating tension and because of her chronic obstructive pulmonary disease and the possibility of respiratory decompression, this opening was left open.A large mesh measuring 3 x 5 inches was then applied in a vertical manner extending from the top part of the midline incision to the navel.This was sutured with interrupted #1 nurolon.After the repair, there was good appearance of the area.Irrigation with normal saline was done.In the meantime, ancef 1 gm intravenously was injected prophylactically.A large axiom stump with sheath was inserted through a separate stab wound and connected to a low continuous suction.The subcutaneous tissue was then sutured with 3-0 vicryl, the skin was closed with skin clips.An abdominal binder was immediately applied.The patient tolerated the procedure well and was taken to the recovery room in satisfactory condition.¿ on (b)(6) 1994: (b)(6) hospital.[illegible, md.] pathology: gross description: ¿the specimen consists of two portions of fibroadipose tissue.One of the specimen measures 2.5 x 3.0 x 1.0 cm, while the other one measures 5.0 x 5.0 x 1.2 cm in greatest dimension.The larger piece shows a saccular appearance and the inner portion is smooth.On cut section, scar tissue is seen.Representative sections of both specimens are submitted in one cassette.Diagnosis: hernia sac with scar and retained suture (ventral ).On (b)(6) 1994: (b)(6) hospital.Dr.(b)(6).Discharge summary.¿she was discharged in satisfactory condition.She was told to see me in the office for followup of the hernia.¿ implant #1 preoperative complaints: on (b)(6) 2003: (b)(6) medical center.Dr.(b)(6).Indications: ¿the patient is a white female with a painful ventral hernia since 1999.Previously she had been counseled due to her anesthesia risk.However, she is being seen now in consultation with anesthesia preop and it was thought that she was stable enough for surgery.She did have a history of constipation, however, she has had a recent flex-sigmoidoscopy and barium enema which had been negative.Her past history was significant for diabetes, coronary artery disease, history of chf, copd, seizures and gout.She had a prior mesh repair of ventral hernia as well.¿ implant #1 procedure: ptfe mesh repair of ventral hernia.[implant: gore® dualmesh® plus biomaterial, /01811685, 10 cm x 15 cm x 1 mm thick, oval] implant #1 date: on (b)(6) 2003 [hospitalization dates unknown] wound classification: not provided.On (b)(6) 2003: (b)(6) medical center.Dr.(b)(6).Operative report.Preop diagnosis: ventral hernia.Postop diagnosis: same.Anesthesia: general.Material to pathology: none.Findings: ¿defect in abdominal wall measuring approximately 4 cm with two small honeycomb areas defect lateral to previous upper mesh repair.¿ procedure: ¿with the patient supine under adequate general endotracheal anesthesia the abdomen was prepped with betadine and povidone and sterilely draped.The previous upper midline incision was sharply opened and part of the old skin broad scar was excised.The excision was taken down through the subcutaneous fat, fascia, and old mesh repair was exposed.The fascia was sharply opened carefully.The underlying adhesions were dissected free.A defect was palpable laterally.The mesh, which appeared to be old marlex mesh was opened and included a defect.The adhesions in the defect were then sharply taken down.The edges were defined.The defect itself measured about 4 x 4 cm.The adhesions were taken down and two small honeycombed areas were detected above and below and these were opened to be included in the fascial defect.Several bleeding edges were controlled with cautery or with ligature.Once the fascial edges had been well defined a small piece of marlex mesh was selected, appropriately trimmed, and sutured in place underneath the fascia using mattress sutures of interrupted 0 prolene suture.Care was taken to have the mesh smooth.The smooth side was kept down.Once the sutures were placed they were all tied closing the defect.The fascia overlying the mesh was closed transversely with a ptfe suture.Hemostasis was assured in the wound with cautery.The subcutaneous tissues were approximated with a running 2-0 vicryl and the skin with staples.Sterile dressings were placed and the patient who tolerated the procedure well was awakened, extubated, and taken to the recovery room in stable condition.Estimated blood loss minimal.Sponge, needle, and instrument count correct.¿ on (b)(6) 2003: (b)(6) medical center.Implant sticker: ¿dualmesh plus antimicrobial¿.Lot: 01811685.Item:.¿ revision preoperative complaints: on (b)(6) 2003: (b)(6) medical center.Dr.(b)(6).Indications: ¿the patient is a (b)(6) diabetic female who has undergone ptfe mesh ventral hernia repair in (b)(6) 2003.She had a postop wound infection but it had then had [sic] done well and closed.She had significant heart disease and had recently been hospitalized at another institution for heart failure.She had been lost to follow-up during that time.She now reported with increasing erythema and pain in her abdominal wall.Her ct scan had shown what was thought to be a wound infection and no intra-abdominal pathology.An i&d of the wound had been performed on the ward.Foul smelling pus had been obtained.The pt.Was markedly improved with local wound care period however, she had persistent drainage and she is brought now to the or for a wider opening of the wound.¿ revision procedure: i&d [incision and drainage] of abscess wound.Exploration, removal of suture, over sew of possible fistula site.Revision date: on (b)(6) 2003 [hospitalization dates unknown] wound classification: not provided.On (b)(6) 2003: (b)(6) medical center.Dr.(b)(6).Operative report.Pre op diagnosis: abdominal wall abscess.Post op diagnosis: same.Possible venticocutaneous [sic] fistula.Anesthesia: general.Material to pathology: none.Findings: ¿abscess cavity fairly clean.There was one area near a prolene suture that was thought to be possible biliary fluid leak was seen [sic].Additional suture removed.No definite bowel seen.The pt.Developed some mild hypotension and because of this the wound was quickly irrigated.The superficial area closed with vicryl sutures and the wound was packed open.¿ procedure: ¿with the pt.[patient] supine under adequate general endotracheal anesthesia the abdomen and previously opened wound was prepped with betadine and povidone and sterilely draped.The wound was opened further in the inferior and superior directions in the old scar.There was another small pocket of pus found inferiorly.The wound was irrigated.Finger dissection was used to make sure there were no loculations.An old prolene suture was seen from the area of the mesh repair, it was noted there was possibly a very tiny small leak of bile stain fluid.The wound was further opened and this area was exposed.The (b)(6) suture was removed and in fact another ptfe suture nearby was removed.There was no definite bowel seen and no further leak seen.The area was closed with interrupted sutures of 3-0 vicryl.At this point the pt.Began to experience some hypotension and it was felt that a more extensive procedure was not warranted.She had a normal ct scan showing no intraabdominal problem.She had no obstructive symptoms.It was felt that this was related to the foreign body of the suture.The wound was then copiously irrigated, it appeared clean.No further pus or drainage seen.The wound was packed open with sterile saline soaked gauze.Sterile dressing was placed.The pt.Who tolerated the procedure well was awakened, extubated and taken to the recovery room.Estimated blood loss minimal.Sponge, needle and instrument counts correct.¿ relevant medication information: on (b)(6) 2003 ¿ discharge date not provided: (b)(6) medical center admission.On (b)(6) 2003: (b)(6) medical center.Dr.(b)(6).Operative report.Pre op diagnosis: recurrent abdominal wall abscess, possible intracutaneous fistula.Post op diagnosis: same.Procedure: i&d of abdominal wall abscess with cultures and curetting.Estimated blood loss: minimal.Material to pathology: cultures, curated granulation tissue.Indications: ¿the patient is a (b)(6) diabetic who had multiple prior repairs of a ventral hernia and who several months ago had a mesh repair and had returned with a superficial infection that eventually proved to be an intracutaneous fistula with tpn [total parenteral nutrition] local care that seemed to heal.She then developed a new abscess in the lower part of the wound area which had been opened on the ward with drainage however recently this had been poorly drained and appeared that there was a recurrence of the intracutaneous fistula.She was brought back now for opening of the abscess cavity for adequate local care control of the fistula and would likely need additional surgery in the future.¿ findings: ¿creamy non foul pus from cavity superficial to the mesh chronic granulation tissue in the cavity above the mesh a slight bit of bilious drainage from the previous i&d site in the superior aspect of the wound.No evidence of fistula communicating with the abscess.¿ procedure: ¿with the patient supine under general endotracheal anesthesia the abdomen was prepped with betadine and povidone and sterilely draped.Previous midline incision was opened inferior to the old i&d site and then hockey stick to include the transverse incision which drained the abscess previously.The cavity was entered, some creamy pus was obtained, it was non foul, there was no bile, pus was cultured for aerobic and anaerobic bacteria.The cavity was further opened sharply, there was found to be some chronic pain granulation tissue diffusely, this was curated and the [sic] cauterized, there was no bilious drainage, no evidence of intracutaneous fistula in the major abscess cavity.The granulation tissue in the upper wound which had nearly closed was also cauterized.Wound edges were anesthetized with marcaine with epinephrine.The wound was then packed with betadine soaked gauze.Sterile dressings were placed.The patient who tolerated the procedure well was awakened, extubated and taken to the recovery room.Sponge/needle and instrument count: correct.¿ explant #1 preoperative complaints:on (b)(6) 2003: (b)(6) medical center.Dr.(b)(6).Indication: ¿the patient is a (b)(6) white female, diabetic, who had undergone multiple ventral hernias repairs in the past, most recently in (b)(6) 2003 when she had some ptfe mesh placed and a small area of hernia.She had multiple prior (b)(6) mesh repairs.She had been lost to follow and had been going to another hospital for care of her congestive heart failure but had returned to her family physician with an abdominal wall abscess.This initially had been drained and done well; however, then she developed signs of intracutaneous fistula.She had a significant cardiac history.An attempt was made to close the fistula and was non operative which was initially successful; however, then she recurred with another abscess in another area.Multiple ct scans had shown that there was no intra-abdominal pathology and that all of the inflammation seemed to be superficial to the mesh; although, there was an obvious intracutaneous fistula.It was felt that there was a foreign body in the fistula that would not heal without removal of the mesh.¿ explant #1 procedure: excision of (b)(6) mesh, small bowel resection, lysis of adhesions, repair of ventral hernia, placement of central line.Explant #1 date: on (b)(6) 2003 [hospitalization dates on (b)(6)2003 ¿ unknown] wound classification: not provided.On (b)(6) 2003: (b)(6) medical center.Dr.(b)(6).Operative report.Preoperative diagnosis: infected abdominal wall mesh with intracutaneous fistula.Postoperative diagnosis: same, plus multiple ventral hernias.Material sent to pathology: excised mesh, portion infected fascia, short segment small bowel.Findings: ¿ptfe mesh.Bile stain but did not seem to be part of the fistula.There was an old marlex mesh and some sutures adherent to the small bowel in the area of the fistula.Short segment of small bowel removed.Primary anastomosis performed.Multiple other small ventral hernias, both cephalad and caudad.Primary fascial closure obtained.¿ procedure: ¿with the patient supine, the left clavicle and thoracic were prepped with betadine and providence.The patient was placed in a trendelenburg.A left subclavian vena puncture was obtained in one pass.A guidewire was passed and a triple lumen catheter was placed in what appeared to be an appropriate position.It was secured in place with multiple sutures.The catheter line was aspirated and flushed well.A sterile dressing was placed.The abdominal dressing was then removed.The abdomen was widely prepped with betadine and povidone, and sterilely draped.There was an area of granulation tissue with some bile leaking through a small opening.In the superior portion of the midline wound, there was also an open wound more inferiorly with packing where the lower abscess had recently been drained.The granulation tissue with the fascia was ellipse and sharply excised down the fascia.The opening was continued down to the abscess drainage site more inferiorly.Multiple sutures were encountered and these were removed.Tedious dissection in the scar in suite.The (b)(6)and the (b)(6) mesh, which had been placed in (b)(6), was able to be identified.It was bile stained but was unattached.It was removed intact.The abdomen was able to be entered superiorly and dissection continued inferiorly freeing the bowel from the mesh and freeing the mesh from the fascia of the mesh.There was fairly large piece of (b)(6) mesh with multiple sutures and it was apparent that the area of the fistula was a hole in the small bowel, adherent to the marlex mesh and one of the sutures.This loop of bowel was able to be freed and the fistula controlled with a babcock clamp.The fascia opening was extended inferiorly.There were several small hernias noted with the incarcerated omentum.The omentum was able to be reduced and the hernias were included in the fascia opening.The very thick and inflamed fascia was obvious (b)(6) and was sharply excised once the undersurface of the fascia had been cleared.Dissection was taken superiorly as well again.Several hernias were found, reduced and included in the fascia opening.There was a peel over the small bowel from the mesh.This was sharply excised.The loop of small bowel with the hole was mobilized.It was quite adherent to the anterior abdominal wall inferiorly on the right and another small enterotomy was made during the mobilization.Eventually a sufficient length of bowel was able to be mobilized and delivered through the wound.It, otherwise, appeared quite healthy.Because of the second enterotomy, the decision was made to excise a short segment of bowel and approximately 4 inch segment of bowel was excised.This was done by opening the mesentery and diving the bowel with the gia.The side to side anastomosis was then performed again with the gia 55.The remaining bowel openings were closed with ta 60.The anastomosis seemed patent.There was no tension.There was good blood supply.No leak seen.There was no mesentery defect that required closure.The bowel was gently replaced.The abdominal cavity was irrigated.Hemostasis was adequate.The decision was made to perform a primary closure of the fascia.Some additional inflamed appearing fascia edges and small pieces of adherent (b)(6) was sharply excised.The fascia was then closed with a running #1 pds buttress by several interrupted #1 pds sutures.The wound was irrigated.Interrupted 2-0 vicryl was used to loosely close the subcutaneous tissue over the exposed sutures.Skin was not closed and the wound was placed [sic] with sterile saline sewed gauze [sic].A dressing was then placed and the patient who had tolerated the procedure well was awaken, extubated and taken to the recovery room in stable condition.Estimated blood loss: 50-75 cc.Sponge/needle/instrument count: correct.¿ on (b)(6) 2003: (b)(6) medical center.Dr.(b)(6).Pathology report: pre-operative diagnosis: expected ventral hernia repair; intracutaneous fistula.Or procedure: wound exploration removal of mesh.Gross description: ¿this specimen is submitted in a partially formalin-filled container which is appropriately labelled with patient¿s name as well as additional information.In this contained further designated ¿#1 ventral hernia sac¿ and ¿#2 segment of small bowel¿ are multiple thin, tough portions of mesh-like material accompanied by segments of soft tissue, and a short segment of small bowel.In aggregate together, the multiple portions of soft tissue measure about 5.5 x 5.5 x 1.5 cm.In maximum size.The portions of identifiable mesh-like material are very thin.Segment of small bowel measures about 5.5 cm.In length.Sections of soft tissue encounter this mesh-like material and sutures throughout.Selected sections of soft tissue are included in the first block.A portion of bowel wall is also separate in the container, a section of which is placed in block 2.Close inspection of the short segment of small bowel demonstrates what appears to be adhesions.Staples are present at either end of the segment.A transverse section of the bowel is submitted in block 3.No abnormality of bowel, aside from the apparent adhesions, is noted.Mucosa appears normal.A small amount of fatty tissue is associated with the segment, sections through which exhibit no usual nodularity.Portions of fecal matter are present in the lumen.¿ microscopic description: ¿included in the first slide are sections of skin and subcutaneous tissue with evidence of acute abscess formation.In slide 2 are sections of small bowel with hemorrhage and focal ulceration of mucosa layers, as well as hemorrhage and adhesions of serosa.The section of small bowel in the third slide appears normal.¿ final diagnosis: ¿skin and subcutaneous tissue with abscess formation consistent with intracutaneous fistula.Segment of small bowel with adhesions.Portion of small bowel tissue with evidence of mucosal ulceration.Multiple segments of mesh-like substance identified.¿ relevant medical information: on (b)(6) 2004: (b)(6) medical center.Dr.(b)(6).Operative report: preoperative diagnosis: recurrent ventral hernia.Postoperative diagnosis: same.Plus retained mesh.Procedure: excision of remained mesh, lysis of adhesions.Repair of ventral hernia.Assistant: sinclair and wilson.Material to pathology: piece of mesh, piece of hernia sac and scar.Cultures of wound.Indications: ¿the patient is a (b)(6) diabetic female who has had multiple repairs of midline ventral hernia including mesh placement in the past.She had developed complication of small bowel fistula into the mesh in the past and had required resection of the bowel and removal of most of the mesh.She had returned however with obvious recurrent hernia and persistent drainage from her umbilicus.The surgery had been delayed because of her coronary artery disease and complications requiring catheterization and stenting and prolonged plavix.She had been hospitalized in april for her symptoms of incarceration which had resolved and she had refused surgery at that time.She is now brought back for repair of her hernia.¿ findings: ¿6 cm.Ventral hernia with some small bowel adhesions.Retained mesh, possibly prolene mesh or marlex mesh with fistula from mesh site to umbilicus.No evidence of small bowel fistula.Primary transverse closure of hernia performed because of the appearance of the infected mesh.¿ procedure: ¿with the pt.[patient] supine under adequate general endotracheal anesthesia the abdomen was prepped with betadine and povidone and sterilely draped.The old midline incision around the umbilicus was sharply excised.Care was taken dissecting down through the scar.Eventually a cavity was entered.It appeared to have granulation tissue and there was a piece of old what appeared to be marlex or prolene mesh in the cavity.The communicated with the umbilicus.There was a fissula [sic] from the bottom of the umbilicus into the cavity.This communicated with the umbilicus.The mesh was sharply excised using mayo scissor and knife dissection.The hernia sac was then able to be sharply opened more laterally on the patient¿s left.The hernia sac was dissected free from the surrounding scar subcutaneous tissue and a portion of it was resected.The defects in the fascia were finally able to be identified, grasped with kocher clamps.Additional sac was excised.There was adherent bowel to the sac and the to the edges of the hernia defect.A tedious sharp dissection was used to free the edges of the hernia.The incision required extension [sic] more cephalad.There was some additional mesh that was also excised, although it appeared to be well incorporated.Once the edges of the hernia were defined the scarred subcutaneous tissue was dissected back from the edges as well.It was decided that primary closure would be performed because of the presence of what had obviously been infected mesh near the umbilicus.All the old scar and granulation tissue was excised in this area.The wound was then closed transversely using a running #1 pds and interrupted prolene sutures.The wound was irrigated and appeared adequately hemostatic.A jp [jackson-pratt] drain was placed above the closure and exited through a separate stab.The base of the umbilicus was sharply debrided.The subcutaneous tissue around the defect was closed with a running 3-0 vicryl.This effectively closed the hole at the base of the umbilicus.The subcutaneous tissue in the wound was then approximated using a running 2-0 vicryl and the skin was stapled.Sterile dressing was placed.The pt.Who tolerated the procedure remarkably well was awakened, extubated and taken to the recovery room ni [sic] stable conditions.Estimated blood loss 50 ccs.Sponge, needle and instrument counts correct.¿ on (b)(6) 2004: (b)(6) medical center.(b)(6).Pathology report: ¿or procedure: repair recurrent ventral hernia.Specimen type: hernia sac.Gross description: ¿this specimen is submitted in a partially formalin-filled container which is appropriately labelled with patient¿s name as well as additional information.In this container further designated ¿hernia sac¿ is a sizable sampling of multiple segments of dense, rubbery fibrofatty and vascular connective tissue and skin which together in aggregate measures about 7 cm.In maximum size.Attempted sectioning of several of these segments demonstrates evidence of repair including suture material and delicate mesh.Thus, only a limited sampling is taken.¿ microscopic dissection: ¿sections of this sizable sampling of multiple segments of tissue demonstrate reparative changes and foreign body giant cell reaction consistent with the diagnosis given above.Additionally, there is a section of skin with similar inflammatory features.¿ final diagnosis: ¿multiple segments of tissue with reparative changes consistent with recurrent ventral hernia repair.¿ multiple areas of foreign material (probably mesh and sutures), identified.¿implant #2 preoperative complaints: on (b)(6) 2005: (b)(6) medical center.Dr.(b)(6).History & physical examination: chief complaint: ventral hernia.History of present illness: ¿the patient is a (b)(6) diabetic female who had a recurrent ventral umbilical hernia.She had multiple operations in the same area including a mesh repair.The mesh had become infected and was removed in (b)(6) 2004 and a primary hernia repair was done.She continued to have some drainage from the umbilical area and repeat ct scan showed a new ventral hernia in the same area.She had no obstructive symptoms.During one of her previous repairs she had been noted to have a small bowel fistula and small bowel resection had been done.She was now for repair and resection of her umbilicus which had never healed and probable mesh.Physician exam: a moderately obese white female, alert, and cooperative in no acute distress.Abdomen: protuberant.She had a scar transversely under umbilicus as well as vertically.There was some thin greenish drainage from the umbilicus.There was a small tract directly in the base of the umbilicus.There was a mild tender bulge to the left.Definite hernia edges could not be palpated.The rest of the abdomen was soft.There were bowel sounds present.Impression: 1.Recurrent ventral hernia.2.Insulin dependent diabetes.#.Ashd [atherosclerotic heart disease] with history of mi [myocardial infarction] and history of chf [congestive heart failure].Plan: repair of recurrent hernia.Excision of chronically infected umbilicus.¿ on (b)(6) 2005: (b)(6) medical center.Dr.(b)(6).Indications: ¿the patient is a (b)(6) diabetic female who has had multiple prior ventral hernia repairs for midline hernia around her umbilicus.She had prior ruptured appendicitis as well as cholecystectomy in the past.She had ha da mesh repair in the past.She had developed a small bowel fistula that had required excision of the mesh repair and primary closure.She had presented with recurrent drainage through her umbilicus and a new hernia laterally on the left near the umbilicus.There was no evidence of obstruction and there was no evidence of cutaneous fistula.Implant #2 procedure: excision of old infected mesh.Excision of umbilicus.Ptfe mesh repair of recurrent ventral hernia.[implant: gore® dualmesh® plus biomaterial,/02767384, x thick, oval].
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H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus biomaterial instructions for use 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 also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.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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