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| Model Number 1DLMCP203 |
| Device Problems
Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
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| Patient Problems
Occlusion (1984); Seroma (2069); Hernia (2240)
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| Event Date 03/08/2017 |
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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 incisional hernia repair on (b)(6) 2006, whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2017, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: seroma, recurrent hernia, removal of mesh, additional surgery, small bowel obstruction.Additional event specific information was not provided.
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Manufacturer Narrative
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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) 2003 were not provided.Operative records dated (b)(6) 2003 indicate the patient underwent incision, drainage, irrigation and packing with quarter inch iodoform for postoperative diagnosis ¿left gluteal abscess, approximately 8 to 10cm with 5 to 6 cm of skin necrosis and slough, multiloculated cavities, tannish colored pus.¿ operative records dated (b)(6) 2003 indicate the patient underwent dilation and curettage exam under anesthesia, total abdominal hysterectomy, bilateral salpingo-oophorectomy, mccall¿s culdoplasty, cystoscopy.Preoperative diagnosis ¿symptomatic fibroid uterus.¿ postoperative diagnosis ¿symptomatic fibroid uterus, pelvis adhesions.¿ operative records dated (b)(6) 2003 state: ¿a vertical midline incision was made down through the skin and subcutaneous tissues, rectus sheath and peritoneum.¿ the records state ¿¿there were adhesions from omental to anterior abdominal wall which were lysed and bleeding point cauterized.Ovarian adhesions were then lysed and cauterized.¿ operative records dated (b)(6) 2005 indicate the patient underwent exploratory laparotomy resection of inflamed colon with functional stapled end to end anastomosis, lysis of adhesions, take down of splenic flexure and appendectomy.Preoperative diagnosis ¿left colon near obstructing lesion on barium enema showing string with need for resection.¿ postoperative diagnosis ¿acute inflammatory lesion approximately 13 centimeters in length with resection of left colon.¿ operative records dated (b)(6) 2005 state: ¿vertical incision was made above the umbilicus to the mid-epigastrium.Incision was carried down with #10 knife blade and electrocautery.Large epigastric hernia was noted and this was taken down.The incision was continued down in superior and inferior fashion.Large amount of omental adhesions were noted at the previous c-section site.These were all taken down.Burkhalter self-retaining retractor was placed.A large inflammatory lesion was noted in the colon from what appeared to be proximal to mid sigmoid to almost the proximal descending colon.This area was gently dissected out with sharp and blunt dissection and electrocautery.¿ operative records dated (b)(6) 2005 state: ¿the bowel was divided distal with ta-55 and inflamed area was so rigid and stiff it was even difficult to try to flex.Continued take down with hemostat times two, divided between, tying with a ligature of 0o vicryl.Splenic flexure was taken down with electrocautery and the lds stapling device until bowel was completely freed.The omentum was freed from the gastrocolic ligament to facilitate better exposure.After adequate distance was noted, we tried to visualize the ureter but there was so much inflammation in the retroperitoneal area unable to visualize even dissect but appeared the retroperitoneum was intact.¿ operative records dated (b)(6) 2005 state: ¿area for proposed resection was trimmed, divided utilizing another ta-55 distal to this divided and excellent repair was noted.Pursestring was then used to place across the sigmoid stump.This was cleared, fired.>> _____ << [sic] was noted and sized to 28 eea.28 anvil head was placed.Pursestring suture was tied.Bowel was opened proximally with electrocautery tinea and this was drained.Trocar was placed, retracted back, lubricated and brought out through the wound.Trocar was removed and anvil head placed.Eea was fired.Appeared to be one defect in the distal donut.Allis hemostat used to repair the enterotomy in the proximal colon.This was sealed with a ta-55.Instrumentation was then irrigated out.¿ operative records dated (b)(6) 2005 state: ¿the patient had all anastomosis reinforced with 3-0 silk.Small mucosal defect was noted at the anastomosis left lateral.This was repaired with a running locking suture of 40 vicryl followed by a 3-0 silk.Excellent repair and cosmesis.The patient's abdomen was filled with water and stool and gas was brought across the anastomosis with no signs of leakage noted.Gloves and gowns were changed.The patient was further irrigated out and no bleeding was noted.Excellent hemostasis was achieved.Appendix was removed with a lds stapling device taking down the mesoappendix and then the base.The base of the appendix was cauterized with electrocautery.¿ operative records dated (b)(6) 2005 state: ¿abdominal cavity further irrigated with sterile normal saline and suctioned dry.Omentum was placed into the pelvis.No other findings were noted.Gallbladder appeared to be normal as was all other contents in the epigastrium.Peritoneum closed with a running 0 vicryl.Fascia closed with running 0 prolene starting at the apices and tying in the midline.Wound as further irrigated with sterile normal saline and suctioned dry.The fatty layer was closed with running 0 vicryl and skin reapproximated with skin stapling device.Prior to closure, the patient had two flat 10- millimeter jackson-pratt drains placed right lower quadrant and placed in the pelvis and left upper quadrant placed next to the anastomosis and inflamed area, brought up through separate stab wounds, sutured in place with 2-0 silk and placed to bulb suction.Wound cleansed with sterile normal saline, blotted dry, covered with adaptic, bulky bandage, drain sponged and taped in place.¿ operative records dated 3/31/2006 indicate the patient underwent incisional herniorrhaphy with anterior rectus rotational flaps and duofilm mesh.Baker tube intestional [sic] decompression and release of small bowel obstruction and massive lysis of adhesions.Preoperative diagnosis ¿incarcerated incisional hernia with small bowel obstruction.Postoperative diagnosis ¿intra-abdominal adhesions with intra-abdominal obstruction and massive extensive adhesions with broad band adhesions with some measuring up to ½ inch in diameter and other were multiple filmy adhesions with pinching of the bowel off.¿ operative records dated (b)(6) 2006 state: ¿the patient had previous epigastric incision and was excised with electrocautery.This was submitted to pathology.Incision was carried down and multiple hernia sacs were noted.A massive hernia was noted in the epigastric area approximately 8-9 cm in diameter with multiple small incisions proceeding vertically.All hernias were distracted and returned back to the abdominal contents.They were not incarcerated at the time of surgery with relaxation.They did reduce but the patient had massive intra-abdominal adhesions.The incision was enlarged in its full length.¿ operative records dated (b)(6) 2006 state: ¿hernia sac was dissected off and the patient had small bowel runs its hold distance releasing multiple thick massive obstructing adhesions and some as much as a quarter to a half inch in diameter.Multiple filmy adhesions were also noted.The patient had the small bowel completely freed.The bleeding points were controlled with hemostats and tied with ligatures of 0 vicryl.The patient had midjejunal area with a small pursestring suture was made with a 3-0 silk.This was then incised with electrocautery and baker tube was inserted and run proximal and distal decompression approximately 3000 cc of fluid.¿ operative records dated 3/31/2006 state: ¿the patient had baker tube removed and excellent decompression was noted.The bowel was very swollen and thickened.She had been obstructed for a considerable period of time.Baker tube was removed.Pursestring suture was tied and then followed with interrupted 3-0 silk.The patient was examined and no other findings were noted.Abdominal cavity was clear.The patient's previous colon resection area was noted as was lack of appendix.The gallbladder was noted without any stones.The patient's nasogastric was in the gastric lumen.No other findings were noted.¿ operative records dated (b)(6) 2006 continue: ¿abdominal contents were returned back to anatomical position.The hernia defect was quite tight and was unable to be closed in any fashion.The patient had the fat dissected from the rectus fascia with electrocautery in all directions.It was elected to repair the patient with mesh but the mesh would have been in contact with the bowel.The anterior rectus fashion was taken in a door fashion.This was incised and taken down and rotated medially, right and left sides.All oozing points were meticulously controlled with electrocautery.Excellent hemostasis was achieved.The patient then headache all area examined.No other findings were noted.The abdominal cavity was copiously irrigated with the use of sterile normal saline and suctioned dry.Jackson-pratt drain was placed in the pelvis and brought out through a separate stab wound.¿ operative records dated (b)(6) 2006 state: ¿the patient then had anterior rectus flaps rotated medially and closed in the midline with a running 0 prolene.Excellent reapproximation closure was noted.The patient them had the area irrigated out and suctioned dry.All oozing points were controlled with electrocautery.The patient had a dualmesh, gore-tex with fibrin ingrowth areas on the outer size.Gore-tex side was placed against the abdominal wall and this was sewn in place with running 0 prolene in all areas.¿ operative records dated (b)(6) 2006 state: ¿no undue tension was noted.Good closure was noted.The further irrigated with sterile normal saline, suctioned dry and no bleeding was noted.Jackson-pratt was placed overlying the mesh and brought out through a separate stabwound.The patient then had the fatty layers closed in multiple layers with running 0 and 3-0 vicryl.The skin was reapproximated with running 3-0 vicryl.The skin was further reapproximated with skin stapling device.Drains were sutured in place with 3-0 ethilon with bulb suction.The wound was cleansed with sterile normal saline and blotted adaptic and bulkage and taped in place.The records confirm a gore® dualmesh® plus biomaterial ((b)(4)) was used during the procedure.A pathology report dated (b)(6) 2006 regarding a specimen obtained (b)(6) 2006 states: tissues ¿hernia, incisional.¿ gross description: ¿in formalin labeled "hernia sac are three pieces of fibrofatty and membranous connective tissue that weigh 49 grams in aggregate.The fragments measure 14 x 7 x 1.5 cm when spread out.Representative sections are in a single cassette.Microscopic description: performed.Final diagnosis: soft tissue, incisional, hernia sac.¿ operative records dated (b)(6) 2008 indicate the patient underwent umbilical herniorrhaphy with excision of umbilicus with drainage of abdominal wall fluid collection with cytology and gram stain, culture and sensitivity.Preoperative diagnosis: ¿abdominal pain with umbilical hernia, status post large incisional hernia with a small amount of fluid overlying the old mesh site.¿ postoperative diagnosis ¿umbilical hernia approximately 2-cm with a large amount of incarcerated small bowel with aspiration of approximately 30ml of cloudy, clear fluid from above the old mesh site.¿ operative records dated (b)(6) 2008 state: ¿the patient had a periumbilical incision made in a vertical fashion.It was dissected out.A large hernia.Sac was noted.This was gently dissected out.Contents had been reduced.The hernia sac was dissected from the surrounding structures including the umbilical skin, dissected down to the fascia.The fascia was clear surrounding the area.It appeared the defect was approximately 2 cm.The hernia sac was opened.It was noted to have a small adhesion attaching the small bowel to the area of the dome of the hernia.The small bowel was delivered.¿ operative records dated (b)(6) 2008 state: ¿the adhesion was cut, but it appeared to be that there might be a small serosal tear.This was repaired with a 3-0 silk on the serosa.No other findings were noted.Abdominal contents were returned to their anatomic position.Hernia sac was excised with electrocautery.The patient was examined.No other findings were noted.No bleeding was noted.The fascial defect was closed with figure-of-eight sutures of 0 nurolon.All sutures were placed.Good fascial attachment was noted, and then they were all tied, taking care to avoid any abdominal contents getting entrapped.¿ operative records dated (b)(6) 2008 state: ¿the patient was then liberally anesthetized with marcaine 0.5% without epinephrine in all areas including the skin.We elected to remove the umbilicus instead of repairing it.The area was irrigated, and no bleeding was noted.Excellent hemostasis was achieved.Prior to closure, the patient had a large fluid collection overlying the epigastric mesh area.A 14-gauge angiocath was placed and drained this with the angiocatheter in place.Approximately 30 ml of clear white fluid was noted.This was submitted for cytology, gram stain, aerobic and anaerobic culture and sensitivity.¿ operative records dated (b)(6) 2008 state: ¿complete reduction was noted.No other fluid was noted.It was elected not to open this area into the incision for possible contamination.The wound was then closed with interrupted 0 vicryl.Skin was approximated with interrupted 0 vicryl and then closed with the skin stapling device after further marcaine 0.5% without epinephrine.The patient was cleansed with sterile normal saline, blotted dry, covered with adaptic, bulky bandage and taped in place.¿ ccytology, gram stain, aerobic and anaerobic culture and sensitivity reports for the specimen obtained on (b)(6) 2008 were not provided.A pathology report dated 4/10/2008 for a specimen collected (b)(6) 2008 states: ¿tissues: hernia sac.Gross description: in formalin labeled "hernia sac" is a 10 x 6.5 x 1cm piece of purplish-tan fibromembranous tissue.Partially submitted in a single cassette.Final diagnosis: soft tissue-hernia sac with fibrosis, chronic inflammation and hemorrhage.¿ ultrasound of abdomen dated (b)(6) 2015 for indication left upper quadrant pain states: ¿impression: unremarkable study.¿ ct abdomen/pelvis dated (b)(6) 2015 for indication low abdominal pain.¿findings: ¿ a large fluid collection associated with a previous hernia repair is seen in the subcutaneous region measuring 10.3 x 17.9 by 15 cm compatible with a seroma.No evidence of herniated bowel is demonstrated into the subcutaneous tissues as the patient on the prior study 2008.The bladder and gastrointestinal tract appears normal.No free fluid or free air is seen in the intra-abdominal cavity.¿ operative records dated (b)(6) 2015 indicate the patient underwent excision of seroma capsule wall and drainage of seroma.Preoperative and postoperative diagnosis ¿incisional hernia seroma.¿ operative records dated 9/8/2015 state: ¿a left lateral vertical incision was made and carried down to the subcutaneous tissue using electrocautery surgery.The seroma could be identified and palpated.It had a thickened capsule.A portion of the wall approximately 8 cm in diameter was removed to be sent to pathology.The seroma fluid was dark brown in nature.A soft tissue substance throughout the wound had concerns for infectious source.The area was then irrigated with copious amounts.The soft tissue remnants were removed.Cultures had been taken.At this point, mass could be identified and was easily seen in the base of this seroma formation.She did get preoperative antibiotics of ancef.The wound was then closed in layers using vicryl suture and skin staples.¿ a pathology report dated (b)(6) 2015 for a specimen collected (b)(6) 2015 states: ¿specimen source: seroma capsule.Gross description: in formalin labeled "seroma capsule" is an aggregate of brownish-orange tissue measuring approximately 11 x 10 x 1.3 cm in aggregate.The tissue forms a membranous lining of variably thickness, with focal adherent loose fibrinous proteinaceous substance.Representative sections are in 4 cassettes.Final diagnosis: benign fibrous walled-cyst with fibrinous proteinaceaous material, consistent with seroma capsule (wall).¿ ct abdomen/pelvis dated 1/21/2017 for indication-abdominal pain states: ¿impression: previous hernia repair with fluid now noted about the mesh graft anteriorly.Abnormal multiple dilated loops of fluid-filled bowel with some nondilated small bowel in the right lower quadrant suggesting a mechanical small-bowel obstruction.Xray abdomen dated (b)(6) 2017 for indication-generalized abdominal pain states ¿impression adynamic ileus.Operative records dated (b)(6) 2017 indicate the patient underwent repair of recurrent incarcerated incisional hernia, placement of strattice 30 x 20cm, open right hemicolectomy, lysis of adhesions, removal of old mesh, small bowel resection, omentectomy, placement of wound vac less than 50cm.Preoperative and postoperative diagnosis ¿resent small bowel obstruction, history of diverticulitis, recurrent incarcerated incisional hernia, perimesh seroma, and intraabdominal adhesive disease.¿ the operative records dated 3/8/2017 state: ¿the patient is a very pleasant lady who has recurrent incarcerated incisional hernia.She has a significant amount of seroma around her mesh, looked like a dual layered mesh that has fluid on top and between the layers.She also had a recent small-bowel obstruction.Plan is for removal of her mesh with repair of recurrent hernia.¿ operative records dated 3/8/2017 state: ¿i opened her midline incision and i ellipsed out the previous scar and medially entered the large seroma, drained about a half liter.I dissected down and encountered the outer layer of the mesh.I split this in between the 2 leaflets of the mesh and drained a lot more fluid out of it.I then was able to get around and split that piece of mesh, and fully split the mesh in half and essentially formalized the midline incision.I then removed the mesh.¿ operative records dated 3/8/2017 state: ¿actually after doing this, realized the mesh was actually an onlay and i think it was a piece of gore dualmesh or at least something similar to that and was in an onlay fashion, on top of the rectus muscles and i removed the top layer from the subcutaneous tissue and then removed the bottom layer from off the anterior sheath trying to preserve this best i could.There was a fair amount of adhesions that i had to take down also to facilitate this.After doing this, i then proceeded to lyse all of her small bowel adhesions, she had 1 dense band that was stuck to her mesentery of the right colon and upon looking at the right colon and into the transverse colon which was extremely inflamed over about a feet long segment and the mesentery was edematous and was just densely adherent.¿ operative records dated 3/8/2017 state: ¿i felt like this had to be resected.I finally finished getting all the adhesions freed up and right above this loop of bowel that was stuck to the inflammatory area of the right colon that was densely significantly dilated up above that.The segment of small bowel had to be resected and i removed it with gia stapling device and performed side-to-side and end-to-end stapled anastomosis.I closed the mesenteric defect.I felt like there was no way to preserve the right colon considering how inflamed it was, initially unsure what the pathology was, took down the lateral attachments and mobilized the transverse colon.I got very soft it about mid transverse colon.¿ operative records dated (b)(6) 2017 state: ¿i transected the terminal ileum with gia stapling device and transected the mesentery with the ligasure and sent this to pathology with the initial appearance suggestive of diverticular disease.I then performed a side-to-side functional end-to-end stapled ileocolonic anastomosis and this was returned to the abdomen.There was a lot of omentum that had to essentially devascularized as part of my dissection and so i resected a large portion of omentum and sent it to pathology also.¿ the operative records dated (b)(6) 2017 state: ¿the abdomen was inspected.It was hemostatic.It was irrigated clean.I then placed a piece of strattice mesh intraabdominal and using the loop pds, i secured it in with the closing the fascia back to itself using a double-stranded looped pds.I resected a lot of redundant extra skin and then i closed most of the incision with skin staplers but the middle portion which she had the large seroma cavity.I left a little area open and placed a wound vac sponge and then applied the vac in standard fashion.¿ a pathology report dated (b)(6) 2017 regarding a specimen collected (b)(6) 2017 states: diagnosis: 1.¿old mesh, removal: mesh, as described grossly.2.Omentum, omentectomy: congestion.Benign reactive lymph node (0/1).3.Colon, right and transverse, resection: acute and chronic diverticulitis with wall abscesses.Polypoid benign colonic mucosa with lymphoid follicles.Status post appendectomy, remote.Nine benign reactive nodes (0/9).No malignancy 4.Small bowel, partial resection: benign small bowel segment.Serosal fibrosis and adhesions.No malignancy identified.5.Skin and soft tissue, abdomen, excision: benign cystic space, suggestive of organized seroma.Small soft tissue abscess.No malignancy identified.¿ gross: ¿specimen #1 designated "old mesh" is received in formalin in a container labeled with the patient¿s name and medical record number and consists of two large sheets of synthetic mesh which measures 14.5 x 9.5 x 11.5 x 9.5 x 2.0 cm.This specimen is submitted for gross analysis only.Specimen #2 designated "omentum" is received in formalin in a container labeled with the patient¿s name and medical record number and consists of an irregularly shaped fragment of omentum that measures 15 x 8 x 1.5 cm.The omentum is serially sectioned and no tumor grossly appreciated.Representative sections submitted in "2a" and "2b".Specimen #3 designated "right and transverse colon" is received in formalin in a container labeled with the patient's name and medical record number and consists of a segment of colon which measures 20 cm in length from ileocecal valve to distal colonic resection margin.A segment of small bowel is also present which measures 6.0 cm in length from ileocecal valve to proximal small bowel resection margin.No appendix is grossly appreciated.Several diverticula are appreciated.A small polyp is appreciated which is 4.0 cm from the distal colonic resection margin.This small polyp measures 0.3 x 0.3 cm.Several areas of abscess are appreciated.Sections are submitted as "3a¿ - ¿3b¿ diverticulum, "3c¿- small polyp, "3d¿ - distal colonic resection margin, "3e¿- proximal small bowel resection margin, "3f¿- abscess, "3g¿- abscess, "3h¿ - "3k¿-.Lymph nodes.Specimen #4 designated "small bowel" is received in formalin in a container labeled with the patient¿s name and medical record number and consists of a short segment of small bowel which measures 9.0 cm in length.Areas of adhesions are noted on the serosal surface.Small bowel is opened, no tumors seen, no necrotic areas seen.Representative sections are submitted as "4a" - resection margins, "4b" - "4c¿ -fibrous adhesions.Specimen #5 designated "abdominal skin" is received in formalin in a container labeled with the patient's name and medical record number and consists of an ovoid pigmented skin which measures 17.5 x 5.5 x 3.0 cm.The specimen is sectioned to reveal a cyst containing viscous yellow liquid.No other anomalies are grossly appreciated.Representative sections submitted in "5a¿- ¿5b.¿.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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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: ??/??/??: [missing records: records for the ¿recurrent incisional hernia repairs x 2¿ were not provided.] (b)(6) 2006: [missing records: records for the ¿recurrent incisional hernia repair with alleged gore device¿ were not provided.] product identification records for the alleged gore device were not provided.(b)(6) 2017: (b)(6) medical center.(b)(6), md.History and physical.Chief complaint: small bowel obstruction.History of present illness: transferred from delta regional medical center for small bowel obstruction, significant abdominal surgical history, colectomy in 2004 for diverticular disease.Developed incisional hernia and had 2 recurrences since then.Has what appears to be dualmesh in place, fluid surrounding mesh within the mesh.Reports that it has been drained in (b)(6) 2015.Has been doing well since until friday when she began to have crampy abdominal pain with nausea and vomiting.Reports had 2 bowel movement yesterday.Had ct of abdomen and pelvis which revealed small bowel obstruction with fluid noted outside and inside of the mesh graft.History: diverticulitis, recurrent incisional hernias with repair x 3, morbid obesity, colectomy for diverticulitis, hysterectomy.Examination: area of bulging to the left of midline incision.Mildly tender to palpation midline.Impression: small bowel obstruction, seroma formation anterior and within the mesh, morbid obesity, hypertension.Plan: currently not nauseated or vomiting.Continue on clear liquids and watch closely.Repeat ct scan of abdomen and pelvis to evaluate obstruction.With fluid anterior and within mesh, likely will need to have a repair and exploration in the future.If she becomes nauseated or vomiting, will place ng tube for decompression.(b)(6) 2017: (b)(6) medical center.(b)(6), md.Radiology-ct abdomen/pelvis.Indication: sbo [small bowel obstruction].Findings: there is a prominent fluid collection with air-fluid levels identified along the medial side of the liver extending into the lower pelvic region along the anterior abdomen.This is adjacent to bowel loops, but does not appear to be a bowel loop.This could be a large abscess.There is also a fluid collection which has a crescent shaped along the midline subcutaneous fat, just anterior to the anterior abdominal wall fascia.This measures up to at least 17.0 x 5.8 cm in greatest transverse diameter.A linear foreign body in this area could be perhaps related to a previous ventral hernia repair.A large fluid collection could be a seroma or abscess.Impression: large midline fluid collection in the subcutaneous fat just anterior to the anterior abdominal wall fascia with some type of linear foreign body within the collection.This could be a postoperative seroma or abscess.I suspect this is related to a prior ventral hernia repair, but would recommend clinic correlation.There is a large fluid collection with air fluid levels noted to extend along the medial side of the liver and inferiorly into the midline pelvic region anteriorly.Abscess cannot be excluded.Mild inflammatory changes in 1 area surrounding the cecum of uncertain etiology, but certainly diverticulitis must be a consideration.(b)(6) 2017: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: seroma around the old hernia mesh.Postoperative diagnosis: seroma around the old hernia mesh.Procedure: drainage of peri-mesh seroma.Assistant: none.Estimated blood loss: minimal.Complications: none.Counts: correct.Indications: ¿the patient is a pleasant lady with a seroma adjacent to mesh that was placed in over 10 years ago.It was concerned that it was infected.The plan is for aspiration and culture.The risks, benefits, and alternatives were discussed with her in detail and she wished to proceed.¿ description of procedure: ¿the patient was taken to the operating room and laid in supine position on the or table.After satisfactory induction of general anesthesia without complication, her abdomen was prepped and draped in standard fashion.I accessed the area with an 18-gauge needle and drained a little over 100 ml of serosanguineous fluid.It was sent for culture.She tolerated this well.Band-aid was applied.¿ (b)(6) 2017: (b)(6) health.Laboratory.Microbiology.Source: abdominal fluid abdomen.Acid fast smear: auramine-rhodamine stain ¿ no acid fast bacilli.Afb culture: no acid fast bacilli isolated.(b)(6) 2017: (b)(6) medical center.(b)(6), md.Discharge summary.Admission date: (b)(6) 2017.Discharge date: (b)(6) 2017.Discharge diagnosis: small bowel obstruction, seroma around old hernia mesh concern for infection, status post drainage of peri mesh seroma, morbid obesity, hypertension.Hospital course: bowel obstruction resolved with nonoperative management.Did undergo drainage of the peri mesh seroma, tolerated this well.Cultures sent off.Initial cultures reveal no growth.Started on clear liquids and advanced as tolerated to soft diet.Bowels were functioning, reached maximum benefit of hospitalization, will be discharged home, plan to follow up in office in 4 to 6 weeks.(b)(6) 2017: (b)(6).(b)(6), md.Office notes.Nausea and abdominal pain better.Current every day smoker.Impression: postoperative visit, tobacco abuse, recurrent incisional hernia.Plan: smoking cessation.Incisional hernia repair, recurrent, open post for 1st week of march.(b)(6) 2017: (b)(6) medical center.(b)(6), md.Operative report.Preoperative diagnosis: recent small-bowel obstruction.History of diverticulitis.Recurrent incarcerated incisional hernia.Perimesh seroma.Intraabdominal adhesive disease.Postoperative diagnoses: recent small-bowel obstruction.History of diverticulitis.Recurrent incarcerated incisional hernia.Perimesh seroma.Intraabdominal adhesive disease.Procedure: repair of recurrent incarcerated incisional hernia.Placement of strattice 30 x 20 cm.Open right hemicolectomy.Lysis of adhesions.Removal of old mesh.Small bowel resection.Omentectomy.Placement of wound vac less than 50 cm.Assistant: (b)(6), pa.Estimated blood loss: 250.Complications: none.Counts: correct.Indications: ¿the patient is a very pleasant lady who has recurrent incarcerated incisional hernia.She has significant amount of seroma around her mesh, looked like a dual layered mesh that has fluid on top and between the layers.She also had a recent small-bowel obstruction.Plan is for removal of her mesh with repair of recurrent hernia.The risks and alternatives were discussed with her in detail and she wished to proceed.¿ description of procedure: ¿the patient was taken to the operating room where she was laid in supine position on the or table.After satisfactory induction of general anesthesia without complication, her abdomen was prepped and draped in standard fashion.I opened her midline incision and i ellipsed out the previous scar and medially entered the large seroma, drained about a half liter.I dissected down and encountered the outer layer of the mesh.I split this in between the 2 leaflets of the mesh and drained a lot more fluid out of it.I then was able to get around and split that piece of mesh, and fully split the mesh in half and essentially formalized the midline incision.I then removed the mesh.Actually after doing this, realized the mesh was actually an onlay and i think it was a piece of gore dualmesh or at least something similar to that and was in an onlay fashion, on top of the rectus muscles and i removed the top layer from the subcutaneous tissue and then removed the bottom layer from off the anterior sheath trying to preserve this best i could.There was a fair amount of adhesions that i had to take down also to facilitate this.After doing this, i then proceeded to lyse all of her small bowel adhesions.She had 1 dense band that was stuck to her mesentery of the right colon and upon looking at the right colon and into the transverse colon which was extremely inflamed over about a feet long segment and the mesentery was edematous and was just densely adherent.I felt like this had to be resected.I finally finished getting all the adhesions freed up and right above this loop of bowel that was stuck to the inflammatory area of the right colon and that was densely significantly dilated up above that.The segment of small bowel had to be resected and i removed it with gia stapling device and performed side-to-side and end-to-end stapled anastomosis.I closed the mesenteric defect.I felt like there was no way to preserve the right colon considering how inflamed it was, initially unsure what the pathology was, took down the lateral attachments and mobilized the transverse colon.I got very soft it about mid transverse colon [sic].I transected the terminal ileum with gia stapling device and transected the mesentery with the ligasure and sent this to pathology with the initial appearance suggestive of diverticular disease.I then performed a side-to-side functional end-to-end stapled ileocolonic anastomosis and this was returned to the abdomen.There was a lot of omentum that had to essentially devascularized [sic] as part of my dissection and so i resected a large portion of omentum and sent it to pathology also.The abdomen was inspected.It was hemostatic.It was irrigated clean.I then placed a piece of strattice mesh intraabdominal and using the loop pds.I secured it in with the closing the fascia back to itself using a double-stranded looped pds.I resected a lot of redundant extra skin and then i closed most of the incision with skin staplers but the middle portion which she had the large seroma cavity.I left a little area open and placed a wound vac sponge and then applied the vac in standard fashion.She tolerated the procedure well.I elected to leave her intubated due to the length of the procedure as well as having a new tight hernia repair and her obesity.She tolerated the procedure well, was allowed to awaken from anesthesia without complication, and transferred to the recovery room in stable condition.¿ (b)(6) 2017: (b)(6) health.Laboratory.Microbiology.Source: abdominal wall.Gram stain: no bacteria seen.Miscellaneous culture: no growth.Source: abdominal wall associated w/ mesh.Gram stain: rare white blood cells.No bacteria seen.Miscellaneous culture: no growth.Source: tissue #2 abdominal wall associated w/ mesh.Gram stain: no bacteria seen.Tissue culture: no growth.Source: abdominal wall.Anaerobic culture: no anaerobes isolated.Source: abdominal wall associated with mesh.Anaerobic culture: no anaerobes isolated.Source: abdominal wall.Koh prep: no fungi seen.Fungal culture: no fungus seen isolated after 4 weeks.Source: abdominal wall associated with mesh.Koh prep: no fungi seen.Fungal culture: no fungus seen isolated after 4 weeks.Source: tissue #2 abdominal wall associated w/mesh.Koh prep: no fungi seen.Wright¿s stain for fungus: no fungi seen.Fungal culture: no fungus seen isolated after 4 weeks.Source: abdominal wall associated w/mesh.Acid fast smear: auramine-rhodamine stain ¿ no acid fast bacilli.Afb culture: no acid fast bacilli isolated.Source: tissue #2 abdominal wall associated w/mesh.Acid fast smear: auramine-rhodamine stain ¿ no acid fast bacilli.Afb culture: no acid fast bacilli isolated.(b)(6) 2017: (b)(6) health.(b)(6), md.Pathology.Accession #: ni.Clinician: (b)(6), md.Diagnosis: 1) old mesh, removal: mesh, as described grossly.2) omentum, omentectomy: congestion; benign reactive lymph node.3) colon, right and transverse, resection: acute and chronic diverticulitis with wall abscesses; polypoid benign colonic mucosa with lymphoid follicles; status post appendectomy, remote; nine benign reactive lymph nodes; no malignancy identified.4) small bowel, partial resection: benign small bowel segment; serosal fibrosis and adhesions; no malignancy identified.5) skin and soft tissue, abdomen, excision: benign cystic space, suggestive of organized seroma; small soft tissue abscess; no malignancy identified.Note: the diagnosis rendered is based upon gross and microscopic examination.History/clinical dx: recurrent incisional hernia.Recurrent incisional hernia repair.Gross: 1) old mesh.2) omentum.3) right and transverse colon.4) small bowel.5) abdominal skin.Specimen #1 designated ¿old mesh¿ is received in formalin in a container labeled with the patient¿s name and medical record number and consists of two large sheets of synthetic mesh which measures 14.5 x 9.5 and 11.5 x 9.5 x 2.0 cm.This specimen is submitted for gross analysis only.Specimen #2 designated ¿omentum¿ is received in formalin in a container labeled with the patient¿s name and medical record number and consists of an irregularly shaped fragment of omentum that measures 15 x 8 x 1.5 cm.The omentum is serially sectioned and no tumor grossly appreciated.Representative sections submitted in ¿2a¿ and ¿2b¿.Specimen #3 designated ¿right transverse colon¿ is received in formalin in a container labeled with the patient¿s name and medical record number and consists of a segment of colon which measures 20 cm in length from ileocecal valve to distal colonic resection margin.A segment of small bowel is also present which measures 6.0 cm in length from ileocecal valve to proximal small bowel resection margin.No appendix is grossly appreciated.Several diverticula are appreciated.A small polyp is appreciated which is 4.0 cm from the distal colonic resection margin.This small polyp measures 0.3 x 0.3 cm.Several areas of abscess are appreciated.Sections are submitted as ¿3a¿ ¿ ¿3b¿ ¿ diverticulum.¿3c¿ ¿ small polyp.¿3d¿ ¿ distal colonic resection margin.¿3e¿ ¿ proximal small bowel resection margin.¿3f¿ ¿ abscess.¿3g¿ ¿ abscess.¿3h¿-¿3k¿ ¿ lymph nodes.Specimen #4 designated ¿small bowel¿ is received in formalin in a container labeled with the patient¿s name and medical record number and consists of a short segment of small bowel which measures 9.0 cm in length.Areas of adhesions are noted on the serosal surface.Small bowel is opened, no tumors seen, no necrotic areas seen.Representative sections are submitted as ¿4a¿ ¿ resection margins.¿4b¿-¿4c¿ ¿ fibrous adhesions.Specimen #5 designated ¿abdominal skin¿ is received in formalin in a container labeled with the patient¿s name and medical record number and consists of an ovoid pigmented skin which measures 17.5 x 5.5 x 3.0 cm.The specimen is sectioned to reveal a cyst containing viscous yellow liquid.No other abnormalies [sic] are grossly appreciated.Representative sections submitted in ¿5a¿-¿5b¿.Kbb/tb/mt.(b)(6) 2017: (b)(6) medical center.(b)(6), md.Discharge summary.Admission date: (b)(6) 2017.Discharge date (b)(6) 2017.Discharge diagnoses: recent small bowel obstruction.History of diverticulitis.Recurrent incarcerated incisional hernia.Perimesh seroma.Status post repair of recurrent incarcerated incisional hernia.Status post open right hemicolectomy.Status post small bowel resection.Status post removal of old mesh and placement of strattice.Morbid obesity.Hospital course: postoperatively, did well.Sent to icu for postoperative management.Was extubated, did well.Was started on clear liquids, advanced as tolerated, bowels resumed function, was ambulating, pain was controlled.She reached maximum benefit of hospitalization and will be discharged home.Plan to follow up in office 1 to 2 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 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 patient codes h6: updated device code h6: updated conclusion codes previous patient codes (2240, 1984) were 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.Medical records: ¿ the known medical records span (b)(6) 2003 through (b)(6) 2017, and not all records received in this time span (b)(6) 2015 were not provided.Patient information: medical history: ¿ recurrent incisional hernia x3 ¿ diverticulitis ¿ obesity (b)(6) 2017: 305 lbs.; bmi 49.2 prior surgical procedures: ¿ cesarean section ¿ unknown date ¿ multiple hernia repairs ¿ unknown date ¿ 2003: hysterectomy ¿ 2003: incision and drainage of gluteal abscess ¿ 2004: colectomy ¿ 2005: resection of inflamed colon with end-to-end anastomosis, lysis of adhesion, takedown of splenic flexure and appendectomy implant preoperative complaints: ¿ [none provided] implant procedure: incisional herniorrhaphy with anterior recuts rotational flaps and duofilm mesh.Implant: gore® dualmesh® plus biomaterial (03759831/1dlmcp203) 20cm x 30cm x 2mm.Implant date: (b)(6) 2006 ¿ description of hernia being treated: ¿incision was carried down and multiple hernia sacs were noted.A massive hernia was noted in the epigastric area approximately 8-9 cm in diameter with multiple small incisions proceeding vertically.All hernias were distracted and returned back to the abdominal contents.They were not incarcerated at the time of surgery with relaxation.They did reduce but the patient had massive intra-abdominal adhesions.The incision was enlarged in its full length.Hernia sac was dissected off and the patient had small bowel runs its hold distance releasing multiple thick massive obstructing adhesions and some as much as a quarter to a half inch in diameter.Multiple filmy adhesions were also noted.The patient had the small bowel completely freed.¿ ¿abdominal contents were returned back to anatomical position.The hernia defect was quite tight and was unable to be closed in any fashion.¿ ¿ implant size and fixation: ¿the patient had a dualmesh, gore-tex with fibrin ingrowth areas on the outer size [sic].Gore-tex side was placed against the abdominal wall and this was sewn in place with running 0 prolene in all areas.No undue tension was noted.¿ ¿ no post-operative records were provided.Relevant medical information: ¿ (b)(6) 2008: umbilical herniorrhaphy with excision of umbilicus with drainage of abdominal wall fluid collection with cytology and gram stain, culture and sensitivity ¿the patient had a periumbilical incision made in a vertical fashion.It was dissected out.A large hernia sac was noted.This was gently dissected out.Contents had been reduced.The hernia sac was dissected from the surrounding structures including the umbilical skin, dissected down to the fascia.The fascia was clear surrounding the area.It appeared the defect was approximately 2 cm.The hernia sac was opened.It was noted to have a small adhesion attaching the small bowel to the area of the dome of the hernia.The small bowel was delivered.The adhesion was cut, but it appeared to be that there might be a small serosal tear.This was repaired with a 3-0 silk on the serosa.No other findings were noted.Abdominal contents were returned to their anatomic position.Hernia sac was excised with electrocautery.The patient was examined.No other findings were noted.No bleeding was noted.The fascial defect was closed with figure-of-eight sutures of 0 nurolon.¿ ¿prior to closure, the patient had a large fluid collection overlying the epigastric mesh area.A 14-gauge angiocath was placed and drained this with the angiocatheter in place.Approximately 30 ml of clear white fluid was noted.This was submitted for cytology, gram stain, aerobic and anaerobic culture and sensitivity.Complete reduction was noted.No other fluid was noted.It was elected not to open this area into the incision for possible contamination.The wound was then closed with interrupted 0 vicryl.¿ cytology, gram stain, aerobic and anaerobic culture and sensitivity reports for the fluid drained during the (b)(6) 2008 procedure were not provided.¿ (b)(6) 2015: ct abdomen/pelvis: ¿a large fluid collection associated with a previous hernia repair is seen in the subcutaneous region measuring 10.3 x 17.9 by 15 cm compatible with a seroma.No evidence of herniated bowel is demonstrated into the subcutaneous tissues as the patient on the prior study 2008.¿ ¿ (b)(6) (015: excision of seroma capsule wall and drainage of seroma ¿the seroma could be identified and palpated.It had a thickened capsule.A portion of the wall approximately 8 cm in diameter was removed to be sent to pathology.The seroma fluid was dark brown in nature.A soft tissue substance throughout the wound had concerns for infectious source.The area was then irrigated with copious amounts.The soft tissue remnants were removed.Cultures had been taken.At this point, mass could be identified and was easily seen in the base of this seroma formation.¿ ¿ (b)(6) 2015: pathology: ¿benign fibrous walled-cyst with fibrinous proteinaceous material, consistent with seroma capsule wall.¿ ¿ (b)(6) 2017: ct abdomen/pelvis: ¿previous hernia repair with fluid now noted about the mesh graft anteriorly.Abnormal multiple dilated loops of fluid-filled bowel with some nondilated small bowel in the right lower quadrant suggesting a mechanical small-bowel obstruction.¿ ¿ (b)(6) 2017: x-ray abdomen: ¿adynamic ileus.¿ ¿ (b)(6) 2017: ¿significant abdominal surgical history, colectomy in 2004 for diverticular disease.Developed incisional hernia and had 2 recurrences since then.Has what appears to be dualmesh in place, fluid surrounding mesh within the mesh.Reports that it has been drained in (b)(6) 2015.Has been doing well since until friday when she began to have crampy abdominal pain with nausea and vomiting.Reports had 2 bowel movement yesterday.Had ct of abdomen and pelvis which revealed small bowel obstruction with fluid noted outside and inside of the mesh graft.¿ ¿with fluid anterior and within mesh, likely will need to have a repair and exploration in the future.¿ ¿ (b)(6) 2017: ct abdomen/pelvis: ¿large midline fluid collection in the subcutaneous fat just anterior to the anterior abdominal wall fascia with some type of linear foreign body within the collection.This could be a postoperative seroma or abscess.I suspect this is related to a prior ventral hernia repair, but would recommend clinic correlation.There is a large fluid collection with air fluid levels noted to extend along the medial side of the liver and inferiorly into the midline pelvic region anteriorly.Abscess cannot be excluded.¿ ¿ (b)(6) 2017: drainage of peri-mesh seroma ¿i accessed the area with an 18-gauge needle and drained a little over 100 ml of serosanguinous fluid.It was sent for culture.¿ ¿ (b)(6) 2017: microbiology: ¿no acid fast bacilli isolated.¿ explant preoperative complaints: ¿ (b)(6) 2017: ¿nausea and abdominal pain better.¿ ¿incisional hernia repair, recurrent, open post for 1st week of (b)(6).¿ explant procedure: repair of recurrent incarcerated incisional hernia, placement of strattice 30 x 20cm, open right hemicolectomy, lysis of adhesions, removal of old mesh, small bowel resection, omentectomy, placement of wound vac less than 50cm.Explant date: (b)(6) 2017 ¿ ¿i opened her midline incision and i ellipsed out the previous scar and medially entered the large seroma, drained about a half liter.I dissected down and encountered the outer layer of the mesh.I split this in between the 2 leaflets of the mesh and drained a lot more fluid out of it.I then was able to get around and split that piece of mesh, and fully split the mesh in half and essentially formalized the midline incision.I then removed the mesh.Actually after doing this, realized the mesh was actually an onlay and i think it was a piece of gore dualmesh or at least something similar to that and was in an onlay fashion, on top of the rectus muscles and i removed the top layer from the subcutaneous tissue and then removed the bottom layer from off the anterior sheath trying to preserve this best i could.There was a fair amount of adhesions that i had to take down also to facilitate this.After doing this, i then proceeded to lyse all of her small bowel adhesions, she had 1 dense band that was stuck to her mesentery of the right colon and upon looking at the right colon and into the transverse colon which was extremely inflamed over about a feet long segment and the mesentery was edematous and was just densely adherent.I felt like this had to be resected.I finally finished getting all the adhesions freed up and right above this loop of bowel that was stuck to the inflammatory area of the right colon and that was densely significantly dilated up above that.The segment of small bowel had to be resected and i removed it with gia stapling device and performed side-to-side and end-to-end stapled anastomosis.I closed the mesenteric defect.I felt like there was no way to preserve the right colon considering how inflamed it was, initially unsure what the pathology was, took down the lateral attachments and mobilized the transverse colon.I got very soft it about mid transverse colon [sic].I transected the terminal ileum with gia stapling device and transected the mesentery with the ligasure and sent this to pathology with the initial appearance suggestive of diverticular disease.I then performed a side-to-side functional end-to-end stapled ileocolonic anastomosis and this was returned to the abdomen.There was a lot of omentum that had to essentially devascularized [sic] as part of my dissection and so i resected a large portion of omentum and sent it to pathology also.The abdomen was inspected.It was hemostatic.It was irrigated clean.I then placed a piece of strattice mesh intraabdominal and using the loop pds.¿ relevant medical information: ¿ (b)(6) 2017: laboratory: ¿no bacteria seen.¿ ¿no growth.¿ ¿no fungi seen.¿ ¿ (b)(6) 2017: discharge summary: ¿recent small bowel obstruction.History of diverticulitis.Recurrent incarcerated incisional hernia.Perimesh seroma.Status post repair of recurrent incarcerated incisional hernia.Status post open right hemicolectomy.Status post small bowel resection.Status post removal of old mesh and placement of strattice.Morbid obesity.¿ ¿postoperatively, did well.Sent to icu for postoperative management.Was extubated, did well.Was started on clear liquids, advanced as tolerated, bowels resumed function, was ambulating, pain was controlled.She reached maximum benefit of hospitalization and will be discharged home.¿ 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 instructions for use further warn, ¿improper positioning of the smooth, non-textured surface adjacent to fascia 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.Section c1: name: plus antimicrobial product coating manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 03759831 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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