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W.L. GORE & ASSOCIATES GORE DUALMESH PLUS BIOMATERIAL WITH CORDUROY; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCP06 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 10/07/2003 |
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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 laparoscopic ventral hernia repair on (b)(6) 2002, whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2003, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: removal of mesh, additional surgery.Additional event specific information was not provided.
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Manufacturer Narrative
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Added patient weight.Added race.Added medical history.Conclusion code remains unchanged.Records prior to on (b)(6) 2002, including records for total abdominal hysterectomy, were not provided.Operative records dated on (b)(6) 2002 indicate the patient underwent ¿laparoscopic ventral incisional hernia repair with mesh.¿ preoperative/postoperative diagnosis ¿ventral incisional hernia.¿ the records state: ¿[patient] is a 34 year old white female who previously underwent total abdominal hysterectomy approximately one year ago.Six months ago she began noticing a bulge just to the left of the lower midline incision.It had become increasingly large and more painful.¿ operative records dated on (b)(6) 2002 state: ¿an infraumbilical incision was made with a #15 blade.The incision was spread with a hemostat and a veress needle was inserted through the fascia and into the peritoneum.Intraperitoneal placement was confirmed with saline drop test.The peritoneum was then insufflated with carbon dioxide.Once an adequate pneumoperitoneum was obtained a 5 mm trocar was placed through the infraumbilical incision.¿ operative records dated on (b)(6) 2002 state: ¿the abdomen was examined.There was indeed a large ventral hernia defect extending from the midline incision to the left lateral side.Two 10 mm trocars were placed in the lateral mid lower abdomen bilaterally.The camera was variously placed in these trocars to discern the extent of the hernia defect.This was marked externally on the skin with a marking pen.A piece of dual mesh was then fashioned to adequately cover the defect and fashioned in a circular shape by trimming the edges.¿ operative records dated on (b)(6) 2002 continue: ¿marks were also made on the mesh to coincide with the markings on the anterior abdominal wall to facilitate placement once the mesh was placed in the abdomen.Four stay sutures were placed at the lateral aspect and superior mid inferior aspects of the mesh.The mesh was rolled and inserted through the right lower quadrant trocar site after removing the trocar.The trocar was then placed and the mesh was unfurled.The four stay sutures were brought up through the anterior abdominal wall using an endoclose device.Once all four sutures had been placed they were tied externally.¿ operative records dated on (b)(6) 2002 state: ¿the remainder of the mesh was then tacked down using a protack device.A second 5 mm trocar was placed in the left upper quadrant to adequately visualize the entire hernia defect and the entire mesh.The mesh actually extended over the two lateral lower abdominal trocar sites so that no fascial closure was required there.It also extended above the umbilical trocar site.Once the mesh was in place it adequately covered the defect.The abdomen was then allowed to desufflate.The trocar sites were examined for hemostasis.All trocars were then withdrawn.The abdomen completely desufflated and all skin incisions were closed with running 4-0 monocryl subcuticular sutures.Benzoin, steri- strips and dry sterile dressings were applied.¿ the records confirm a gore® dualmesh® corduroy antimicrobial (1dlmcp06/00751001) was used during the procedure.Records between 9/10/2002 and 10/7/2003 were not provided.Operative records dated on (b)(6) 2003 indicate the patient underwent ¿open repair of recurrent ventral hernia with mesh, removal of previous mesh.Preoperative/postoperative diagnosis ¿recurrent ventral abdominal hernia.¿ operative records dated on (b)(6) 2003 state: ¿[patient] is a 35 year old white female who previously underwent laparoscopic ventral abdominal hernia repair.She has developed a recurrent bulge and on ct scan had a recurrent ventral hernia.¿ the records state: ¿her previous lower midline incision was reopened with a #10 blade.The incision was carried down through the subcutaneous tissue using electrocautery.The hernia sac was identified and dissected out circumferentially using the electrocautery.The sac was entered.The previously placed mesh was removed also using the electrocautery and the fascia debrided back to healthy fascial edges.¿ operative records dated on (b)(6) 2003 state: ¿there were also some omental adhesions to the undersurface of the mesh and these were lysed as the mesh was removed.Once the mesh had been completely removed and the fascia debrided, a piece of marlex mesh was used sutured to the undersurface of the fascia using a running #1 prolene suture.The fascia was then reapproximated on top of the mesh, again using running #1 prolene sutures.Subcutaneous tissue was irrigated and examined for hemostasis which was found to be adequate.A 10 french flat jackson pratt drain was placed on top of the fascial repair and brought out through a separate stab incision.The drain was sutured in placed with a 2-0 silk suture.The skin was then closed with staples.A dry sterile dressing was then applied.¿ the records confirm a bard mesh (non-gore device) was used during the procedure.Records between 10/7/2003 and 6/13/2005 were not provided.Medical records dated on (b)(6) 2005 states: ¿she¿s concerned she may have a hernia.Exam, tender off to left of umbilicus.I can¿t feel a defect because of her weight.Will get a ct and see back.¿ ct abdomen report dated on (b)(6) 2005 states: ¿impression: l.Hypodense mass in the left kidney most likely a benign cyst.Ultrasound is recommended.¿ medical records dated on (b)(6) 2005 state: ¿has large ventral/incisional hernia.She has sx¿s.She wants it repaired.Wants to talk about care credit for gastric¿ records also state ¿will do transverse icision [sic] and remove umbilicus.¿ history and physical dated for on (b)(6) 2005 admission to hospital states: ¿the patient has a large hernia and wishes to have this repaired because it causes symptoms of pain.¿ the records state ¿[patient] is a 37-year-old who has obesity and desires a gastric bypass.However, she was denied by her insurance company.She is now back wanting to have her hernia repaired.¿ operative records dated on (b)(6) 2005 indicate the patient underwent 1) open incisional hernia repair with mesh.2) pannuculectomy.Preoperative/postoperative diagnosis ¿1) incisional hernia.2) large pannus.¿ ¿[patient] is a 37-year-old who has a large incisional hernia.This is recurrent.She also has a large pannus.¿ operative records dated on (b)(6) 2005 state: ¿findings: she had a defect with bowel in the defect.This was closed primarily.Old mesh was encountered.The defect was lateral to the mesh.It involved the edge of the mesh.This was closed primarily, and an overlay mesh repair was performed.The mesh overlapped the repair by several inches.A large panniculectomy was performed to aid in this repair.¿ operative records dated on (b)(6) 2005 state: ¿a wide fishmouth incision was made to include the umbilicus.This was carried down into the subcutaneous tissue.Laterally, the fascia was encountered.Perforating vessels were ligated and cauterized.A large panniculectomy was performed including the umbilicus.The defect below the umbilicus and off to the left was encountered.It was opened in the apex.The bowel was easily reduced.The peritoneum was excised down to the fascia, and some of the peritoneum was sent to pathology to confirm this being a hernia.¿ operative records dated on (b)(6) 2005 state: ¿the fascia was then cleaned circumferentially.It was then closed primarily in a transverse manner with looped, #1, pds suture.A large mesh of doubly-layered mesh was then placed over the closure and sewn with a #1 looped pds in a running manner.Two drains were then brought out inferiorly and sewn to the skin with nylon suture.They were placed on top of the mesh.The subcutaneous tissue was then closed with vicryl.The dermis was closed with vicryl.The skin was closed with staples.A sterile dressing was applied.¿ discharge summary dated on (b)(6) 2005 indicate the patient was admitted to the hospital on (b)(6) 2005 for ¿open incisional hernia repair with mesh and panniculectomy.The records state: ¿hospital course: she tolerated the procedure very well.The drain was left in place postoperatively.Hospital course was uncomplicated.Diet was advanced.¿ medical record dated on (b)(6) 2005 states: ¿doing well.Sore.Wound looks great.Drains serosang, will remove on friday.¿ medical record dated on (b)(6) 2005 states: ¿doing good.No problems reported.Drains removed.Will see next week for staple removal.¿ medical record dated on (b)(6) 2005 states: ¿staples out.Incision healing nicely.Ss [steri-strips] applied.No problems reported.¿ medical record dated on (b)(6) 2005 states: ¿pt called, says she went to her pcp this morning for sinus infection, and the dr.Told her that her inc was infected and started her on augmentin.Appt made tomorrow morning for inc check.¿ medical record dated on (b)(6) 2005 states: ¿wanted me to check her drain site.Her pcp told her it was infected.It is not.It looks fine.No cellulitis.No drainage.Wound looks great.¿ medical record dated on (b)(6) 2005 states: ¿incision clean.Draining a little plasma.Given antibiotics.Wound check next week.¿ medical record dated on (b)(6) 2005 states: ¿wound is a lot better according to pt.¿ ¿some erythema middle.No fluctuance.See next week.¿ medical record dated on (b)(6) 2005 states: ¿much better, still some cellultis [sic].Rec 5 more days of levaquin.¿ medical record dated on (b)(6) 2005 states: ¿she feel great.No c/o.Wound looks much better.Not infected.¿ medical record dated on (b)(6) 2005 states: ¿c/o pain in incision at times.Worse with movement.Will wake her up.No fever.Exam, mild cellulitis, will treat with lovaquin.¿ medical record dated on (b)(6) 2005 states: ¿doing well, wound ok.¿ pertinent records dated 10/25/2005 to on 5/8/2012 were not provided.Operative records dated on (b)(6) 2012 indicate the patient underwent ¿laparoscopic ventral hernia repair with mesh.Laparoscopic lysis of adhesions.¿ preoperative/postoperative diagnosis ¿incarcerated ventral hernia.¿ the records state ¿the patient had an approximate 6 x 5 cm fascial defect with incarcerated omentum and colon.¿ operative records dated on (b)(6) 2012 state: ¿a small incision was made in the left upper quadrant.We then used veress needle to insufflate the abdomen.After adequate pneumoperitoneum a 5-mm trocar was then used to enter the abdomen.We then placed a 12-mm port and another 5-mm port.We then took down dense adhesions and took down the posterior fascia.At patient's prior open hernia repair, adhesions were noted.We then got to the incarcerated ventral hernia where there was omentum.This was reduced and we then measured the fascial defect it being 6 x 5 cm.¿ operative records dated on (b)(6) 2012 state: ¿we took down further adhesions until the entire abdominal wall was free of adhesions.This was done with sonosurg.Next we then decided to used [sic] a 16 x 20 cm gore dualmesh.We then used ethibond sutures at the 12, 3, 6, and 9-o'clock positions.We then inserted the mesh and using a suture passer, pulled this up; then using 5-mm protackers we tacked the mesh up to the posterior fascia circumferentially.Afterwards we then placed four more sutures through the fascia at about the 2, 4, 8, and 10-o'clock positions.Lastly after making sure everything was hemostatic we desufflated the abdomen and we then closed our incisions with monocryl reinforced with dermabond and steri-strips.¿ the records confirm a gore® dualmesh® plus biomaterial (1dlmcp04/9600695) was used during the procedure.Records between 5/8/2012 and 1/17/2014 were not provided.Operative records dated on (b)(6) 2014 indicate the patient underwent ¿open incisional hernia repair with inlay posterior rectus mesh repair.¿ preoperative/postoperative diagnosis ¿1.Recurrent incisional hernia, right lower quadrant.2.Severe morbid obesity.3.Hypertension.4.Fibromyalgia.5.Osteoarthritis.Operative records dated on (b)(6) 2014 state: ¿a transverse incision was made along her previous scar overlying the palpable hernia.This was carried down to the subcutaneous tissues using electrocautery until the hernia sac was encountered.A very large hernia sac was circumferentially dissected free from the subcutaneous tissues all the way down to the level of the fascia circumferentially.The fascial defect actually was not large enough.¿ operative records dated on (b)(6) 2014 state: ¿once it was free all the way to the fascia, we separated the sac fully from the fascial edge.At this time, we opened the hernia sac and resected some of the sac.At this point, we attempted to reduced [sic] the contents which included the cecum, right colon, and several loops of small bowel.Due to the small fascial defect, we were unable to reduce all of this, therefore, we did extend the fascial defect laterally.¿ operative records dated on (b)(6) 2014 continue: ¿at this time, we safely reduced the bowel.There was a small serosal tear on the cecum which was oversewn with 3-0 vicryl lembert sutures.Once all the bowel was reduced, we excised the remainder of the excess hernia sac.We then separated the peritoneum and posterior rectus sheath circumferentially from the posterior rectus muscle medially and the external oblique laterally.We continued this dissection circumferentially and then reapproximated the peritoneum laterally and then the peritoneum and posterior rectus sheath medially, all in a running #1 vicryl suture.¿ operative records dated on (b)(6) 2014 state: ¿we then ensured that this space was large enough to place our mesh.An approximately 6 x 8 inch piece of physiomesh was then placed in this preperitoneal posterior rectus space.It was secured in place transvaginally with interrupted nurolon sutures with several stay sutures circumferentially.The fascia was then closed with interrupted nurolon sutures incorporating the mesh with every other suture.¿ operative records dated on (b)(6) 2014 state: ¿the wound was then thoroughly irrigated.Cautery was used for hemostasis.The wound was then closed in several layers with 2-0 vicryl interrupted sutures to decrease the dead space.A jp drain was placed in the wound superficial to the fascia and brought out laterally and secured in place with silk.The skin was closed with skin staples and sterile dressing was applied.¿ records between 1/17/2014 and 11/4/2015 were not provided.Operative records dated on (b)(6) 2015 indicate the patient underwent ¿laparoscopic incisional hernia repair with the da vinci xi robot.¿ preoperative/postoperative diagnosis ¿recurrent incisional hernia.¿ the records state: ¿the hernia was reduced with the scissors and electrocautery above findings abdominal wall were noted.A 20 x 25 cm proceed mesh was then placed into the abdominal cavity and positioned then tacked with 2-0 vicryl's in the 4 corners.The outer edge was then run with 0 prolene v lock sutures.There was approximately 2 cm overlay in all directions.The mesh was then tacked to the abdominal wall with a secure strap in the midline.The abdomen was inspected no bleeding was noted and the ports removed under direct visualization.¿ operative records dated on (b)(6) 2015 also state: ¿the rectus muscles were separated by at least 20 cm with multiple small actual hernias out between this separation.An overllay mesh was therefore used to repair the incisional hernias since it was felt the rectus muscles even with component separation would not be amenable to reapproximation.¿ 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 results code.Conclusion code remains unchanged.
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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 9/10/2002, including records for total abdominal hysterectomy, laparoscopic cholecystectomy, previous hernia repair and gastric bypass, were not provided.01/17/14: trinity medical center.John touliatos, md.History and physical.Cc: abdominal pain.Hpi: presents from outside hospital with a presumed partial small bowel obstruction and incarcerated ventral hernia.Patient states that 4 days ago she started having severe abdominal pain after a fall.She felt like something tore in her right lower quadrant.Since that time, she had several episodes of vomiting that day, but she has only had nausea since tuesday with only 1 episode of emesis.She states that her pain has increased since tuesday.Exam: abdomen: she is moderately tender to palpation over her right lower quadrant, where there is a large incarcerated hernia.A ct of her abdomen and pelvis with contrast was reviewed, and it shows a right lower quadrant hernia containing cecum with some stranding around the incarcerated bowel, and there is mild small bowel dilatation as a result.Plan: incarcerated ventral hernia.3/06/14: advanced surgical weight loss center at trinity.John touliatos, md.Office visit.Hpi: interested in gastric sleeve.Plan: i have recommended laparoscopic sleeve gastrectomy over the bypass given her multiple abdominal operations and hernias we¿ll [sic] make the gastric bypass more difficult and increase her risk of conversion to an open procedure.Given her obesity and propensity of hernias in the past i think this would put her at greater risk of complications in the future.06/18/14: trinity medical center.John touliatos, md.Operative report.Preop diagnosis: morbid obesity.Postop diagnosis: morbid obesity, adhesions.Operative procedure: laparoscopic roux-en-y gastric bypass, antecolic, antegastric with 150 cm limb.Intraoperative egd.Extensive lysis of adhesions.Operative findings: significant adhesions to the anterior abdominal wall.There was somewhat of an eventration of the prior laparoscopic hernia repair with mesh protruding into the hernia sac.Procedure: ¿the patient was taken to the operating room, placed on the table in the supine position.After general anesthesia, she was prepped and draped in the usual fashion.A left upper quadrant incision was made with a scalpel.Abdomen entered with the visiport device.Additional ports placed in usual positions.The adhesions in the midline were taken down sharply with the electrocautery and sonicision, making space for placement of the ports in the right abdomen.Once this was completed, the small bowel was inspected and noted to be remarkably free of adhesions.The liver was then retracted and fat-pad taken off the ge junction, exposing the angle of his.The lesser sac was then entered 6 cm distal to the ge junction with the sonicision, and the stomach divided transversely with the tan load gia, and then the __ [sic] with the tan load through the angle of his with a 34-french bougie in place.The staple lines were inspected and any bleeding was controlled with cautery.The ligament of treitz was identified.The small bowel divided distal to this with the tan load gia.The mesentery __ [sic] with a gray load, where the roux limb was then walked 450 cm and tacked to the proximal limb with 2-0 vicryl in a side-to-side 45 mm anastomosis.With the tan load gia, the remaining defect was closed in a single layer with 2-0 vicryl.The mesentery was closed with 2-0 silk.The roux limb was brought up in antecolic antegastric fashion, tacked to the posterior wall with interrupted 2-0 vicryl, where an end-to-side anastomosis was created with the gia 30 tan load.The remaining defect was closed in 2 layers over a 34-french bougie.The bougie was then removed.The stomach __ [sic] clamp distal to the anastomosis and the olympus video endoscope was inserted.The anastomosis was patent without extravasation of air, without intraluminal bleeding.The scope was then withdrawn.The ports were removed with direct visualization and the wounds were injected with 0.25%marcaine with epinephrine, closed with 4-0 monocryl and dressed with steri-strips.All sponge, needle, and instrument counts were reported as correct.The patient went to the recovery room in stable condition.¿ 07/21/14: trinity medical center.John touliatos, md.Surgery history and physical.Hpi: abdominal pain, back pain attributed to uti.Exam: abdomen; marked tenderness to palpation epigastric region without radiation.Assessment/plan: abnormal ua, low-back and epigastric abdominal pain, nausea and vomiting.07/22/14: trinity medical center.Mary catherine laney, md.Ronald a.Lepke, md.Radiology-upper gi.Indication: epigastric, abdominal pain.Impression: small hiatal hernia and mild gastroesophageal reflux without evidence of other significant abnormality.05/14/15: advanced surgical weight loss center at trinity.John touliatos, md.Office visit.Exam: gi: mass just inferior to the right umbilicus which may be old fat necrosis from prior abdominoplasty or a ventral hernia.It is not tender and not reducible.Check a ct scan of her abdomen to see if these hernias on her abdominal wall as well to evaluate for portal vein thrombosis from july.05/14/15: trinity medical center.Ronald adrian lepke, md.Radiology-ct abdomen/pelvis.Indication: portal vein thrombosis.Impression: interval complete resolution of portal vein thrombosis and inferior mesenteric vein thrombosis as well as interval resolution of central mesenteric injection since the prior study.10/08/15: advanced surgeons, pc trinity.John touliatos, md.Office visit.Hpi: comes in today to discuss repair of her incisional hernia.Exams: gi; rlq, incarcerated, nontender incisional hernia.Plan: i discussed increased difficulty in this is a recurrent incisional hernia multiple times.Ultrasound of this laparoscopically with the da vinci robot but may have to convert to an open procedure.I¿ll most likely have to place the mesh intraperitoneally give her multiple repairs in the past.11/12/15: grandview medical center.Christopher stuart, md.Discharge summary.Admission/discharge diagnosis: recurrent incisional hernia.Procedures: laparoscopic incisional hernia repair with the da vinci xi robot.Hospital course: she tolerated the procedure well without any apparent complications.01/14/16: advanced surgeons, pc grandview.John touliatos, md.Office visit.Exams: gi; fullness right lower quadrant most likely scarring, i do not feel this is any recurrence of the hernia.07/11/16: birmingham gastroenterology.Owen r.Mclean, md.Office visit.Presents with complaint of abdominal pain.Assessment & plan: my primary concern is for bile gastropathy, we will plan egd to evaluate her symptoms.07/14/16: advanced surgeons, pc grandview.John touliatos, md.Office visit.Hpi: she¿s noticed 2 bulges in lower abdomen, seemed to be getting larger, concerned may be hernias.Slightly tender.Exams: gi; 2 areas lower abdomen, firm, not mobile which may be incarcerated recurrent hernias.Assessment: nonreducible ventral incisional hernia.Plan: ct, abdomen, with contrast.07/??/16: [missing records: records for ct abdomen w/ contrast showing ¿fluid collection above the mesh¿ were not provided.] 08/01/16: advanced surgeons, pc grandview.John touliatos, md.Office visit.Hpi: comes in to go over results of ct scan and have seroma aspirated.I discussed with her that there is no hernia just a fluid collection above the mesh.Procedures: visit for surgery aftercare, not elsewhere classified, teeth, oral cavity and digestive syst.After prepping the skin with alcohol swabs and injection with lidocaine.Under ultrasound guidance.We aspirated the fluid from the seroma the right lower abdomen, removing about 20 cc of cloudy fluid.Plan: i sent the fluid for cultures, although i do not suspect infection.I informed her that there are seroma may return but only recommend drain placement or other treatments if it is really bothering her, to try to prevent mesh infection.10/24/17: grandview medical center.Joel a.Mixon, md.Radiology-ct abdomen/pelvis.Reason for exam: abdominal tenderness, unspecified site.Indications: history of multiple prior hernia surgeries with abdominal pain and tenderness.Impression: extensive abdominal postsurgical findings, including the ventral hernia mesh repair with decreasing size of the seroma or focal fat necrosis/oil cysts in the right abdominal wall.There is no evidence of recurrent bowel containing hernia, bowel obstruction or other acute gastrointestinal tract inflammatory process.10/23/17: advanced surgeons, pc grandview.John touliatos, md.Office visit.Abdominal pain with nausea.She states the pain could be from scar tissue from previous surgeries.Pt also states she has had diarrhea after she eats, and has vomited one time three days ago.Multiple hernia repairs in past including onlay mesh as well as attempted laparoscopic repair the defect was so large we did not feel we can get the muscle back together and it was just patched with mesh.Exams: gi: eventration of the abdominal wall.There is some firmness her abdomen, which is likely the mesh which is now palpable.Plan: abdominal pain.I will get a cat scan to make sure there is no residual hernia with incarcerated small intestine.The pain may be secondary to the mesh, but removing the mesh will be quite difficult with a larger problem repairing the abdominal wall subsequently given the size of the defect.If her pain is so severe that she cannot tolerate it any longer, she would likely be seen at a specialized hernia clinic for abdominal wall reconstruction.??/??/17: [missing records: records for the ct scan ordered on 10/23/17 were not provided.] 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 with corduroy® tissue ingrowth surface 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: records prior to 9/04/2002, including records for total abdominal hysterectomy, laparoscopic cholecystectomy, previous hernia repair and gastric bypass, were not provided.09/04/02: surgical arts p.C.Joan w.Iacobelli, md.History & physical.Underwent total abdominal hysterectomy approximately 1 year ago.6 months ago started noticing a bulge left of the incision.Became increasingly large and painful.Does not have any obstructive or incarceration symptoms.Past medical history: lap chole [cholecystectomy].Hysterectomy.Kidney stone x 2.History of ectopic pregnancy.Exam: obese.Gastrointestinal- lower midline incision had a ventral hernia defect to the lateral side of the portion of the incision.Felt to be chronically incarcerated but it was difficult to tell as the patient was quite obese.Impression: ventral incisional hernia.Plan: laparoscopic, possible open, ventral hernia repair with mesh on 09/10/02.09/10/02: cullman regional medical center.Joan iacobelli, md.Operative report.Pre/postoperative: ventral incisional hernia.Procedure: laparoscopic ventral incisional hernia repair with mesh.Pertinent history: ms.Pigg is a 34 year old white female who previously underwent total abdominal hysterectomy approximately one year ago.Six months ago she began noticing a bulge just to the left of the lower midline incision.It had become increasingly large and more painful.She is admitted at this time for laparoscopic repair.Details of procedure: ¿after adequate general endotracheal anesthesia was obtained the patient was prepped and draped in routine sterile fashion.An infraumbilical incision was made with a #5 blade.The incision was spread with a hemostat and a veress needle was inserted through the fascia and into the peritoneum.Intraperitoneal placement was confirmed with saline drop test.The peritoneum was then insufflated with carbon dioxide.Once an adequate pneumoperitoneum was obtained a 5 mm trocar was placed through the infraumbilical incision.The abdomen was examined.There was indeed a large ventral hernia defect extending from the midline incision to the left lateral side.Two 10 mm trocars were placed in the lateral mid lower abdomen bilaterally.The camera was variously placed in these trocars to discern the extent of the hernia defect.This was marked externally on the skin with a marking pen.A piece of dual mesh was then fashioned to adequately cover the defect and fashioned in a circular shape by trimming the edges.Marks were also made on the mesh to coincide with the markings on the anterior abdominal wall to facilitate placement once the mesh was placed in the abdomen.Four stay sutures were placed at the lateral aspect and superior mid inferior aspects of the mesh.The mesh was rolled and inserted through the right lower quadrant trocar site after removing the trocar.The trocar was then placed and the mesh was unfurled.The four stay sutures were brought up through the anterior abdominal wall using an endoclose device.Once all four sutures had been placed they were tied externally.The remainder of the mesh was then tacked down using a protack device.A second 5 mm trocar was placed in the left upper quadrant to adequately visualize the entire hernia defect and the entire mesh.The mesh actually extended over the two lateral lower abdominal trocar sites so that no fascial closure was required there.It also extended above the umbilical trocar site.Once the mesh was in place it adequately covered the defect.The abdomen was then allowed to desufflate.The trocar sites were examined for hemostasis.All trocars were then withdrawn.The abdomen completely desufflated and all skin incisions were closed with running 4-0 monocryl subcuticular sutures.Benzoin, steri-strips and dry sterile dressings were applied.The patient tolerated the procedure well and was returned to the recovery room in stable condition.All sponge, instrument and needle counts were correct.¿ 10/07/03: cullman regional medical center.Joan iacobelli, md.Operative report.Pre/postoperative diagnosis: recurrent ventral abdominal hernia.Procedure: open repair of recurrent ventral hernia with mesh, removal of previous mesh.Pertinent history: ms.Pigg is a 35 year old female who previously underwent laparoscopic ventral abdominal hernia repair.She has developed a recurrent bulge and on ct scan had a recurrent ventral hernia.She is admitted at this time for operative repair.Details of procedure: ¿after adequate general endotracheal anesthesia was obtained, the patient was prepped and draped in routine sterile fashion.Her previous lower midline incision was reopened with a #10 blade.The incision was carried down through the subcutaneous tissue using electrocautery.The hernia sac was identified and dissected out circumferentially using the electrocautery.The sac was entered.The previously placed mesh was removed also using electrocautery and the fascia debrided back to healthy fascial edges.There was also some omental adhesions to the undersurface of the mesh and these were lysed as the mesh was removed.Once the mesh had been completely removed and the fascia debrided, a piece of marlex mesh was used sutured to the undersurface of the fascia using a running #1 prolene sutures.Subcutaneous tissue was irrigated and examined for hemostasis which was found to be adequate.A 10 french flat jackson-pratt drain was placed on top of the fascial repair and brought out through a separate stab incision.The drain was sutured in placed with a 2-0 silk suture.The skin was then closed with staples.A dry sterile dressing was then applied.The patient tolerated the procedure well and was returned to the recovery room in stable condition.All sponge, instrument and needle counts were correct.¿ 10/13/03: cullman regional medical center.Joan iacobelli, md.Discharge summary.Discharge diagnosis: recurrent ventral abdominal hernia.Postoperative fever.Previous history of kidney stones.Operation and special procedures performed during hospitalization: repair of ventral hernia repair performed on 10/07/03.Pertinent history: previously underwent uneventful hernia repair.Developed postoperative fever.Chest x-ray, sinus films, and cbc were normal.Fever subsided spontaneously.Jackson pratt drain in place which had drained 90 cc 24 hours prior to discharge.Incision was healing well at the time of discharge.05/02/12: birmingham minimally invasive surgery, p.C.Vinh nguyen, md.Office note.Reason for visit: stomach ventral hernia.Complains of upper abdominal pain for several months, worsened over the past few weeks.Had open ventral hernia repair with mesh.Ct last week revealed upper left ventral hernia.No nausea/vomiting or obstructive symptoms.Past medical history: nash [non-alcoholic steato-hepatitis].Weight 377.2 lbs.Exam: positive ventral hernia, large, nonreducible.Plan: laparoscopic ventral hernia repair with mesh.05/08/12: st.Vincent¿s east.Vinh nguyen, md.Operative report.Pre/postoperative diagnosis: incarcerated ventral hernia.Operative procedure: laparoscopic ventral hernia repair with mesh.Laparoscopic lysis of adhesions.Operative findings: patient had an approximate 6 x5 cm fascial defect with incarcerated omentum and colon.Estimated blood loss: less than 10 cc.Specimen: none.Mesh used: 16 x 20 cm gore dualmesh.Operative procedure in detail: ¿patient taken to the operating room and placed supine on the operating table.After general anesthesia, patient¿s abdomen was prepped and draped sterilely.A small incision was made in the left upper quadrant.We then used veress needle to insufflate the abdomen.After adequate pneumoperitoneum, a 5-mm trocar was then used to enter the abdomen.We then placed a 12-mm port and another 5-mm port.We then took down dense adhesions, and took down the posterior fascia.At patient¿s prior open hernia repair, adhesions were noted.We then got to the incarcerated ventral hernia, where there was omentum.This was reduced, and we then measured the fascial defect, it being 6 x5 cm.We took down further adhesions until the entire abdominal wall was free of adhesions.This was done with sonosurg.Next, we then decided to used [sic] a 16 x 20 cm gore dualmesh.We then ethibond sutures at the 12, 3, 6, and 9-o¿clock positions.We then inserted the mesh and, using a suture passer, pulled this up; then using 5-mm protackers, we tacked the mesh up to the posterior fascia circumferentially.Afterwards we then placed four more sutures through the fascia at about the 2, 4, 8, and 10-o¿clock positions.Lastly, after making sure everything was hemostatic, we desufflated the abdomen, and we closed our incisions with monocryl reinforced with dermabond and steri-strips.The patient tolerated the procedure well.Needle, sponge, and instrument counts were correct at the end of the case.¿ 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 with corduroy® tissue ingrowth surface 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.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 with corduroy® tissue ingrowth surface 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: (b)(6) 20004: (b)(6) medical center.[illegible].Gastro-intestinal procedure report.Procedure: egd [esophagogastroduodenoscopy] with biopsy.Preoperative diagnosis: h.Pylori +, reflux.Asa 2.Findings: gastritis, biopsy antrum, hiatal hernia.(b)(6) 2004: (b)(6) medical center [assigned].(b)(6) md.Esophagogastroduodenoscopy report.Pre-endoscopy diagnosis: obesity, gerd [gastro esophageal reflux disease], h.Pylori +.Post-endoscopy diagnosis: same, hh [hiatal hernia], gastritis.Procedure: egd with biopsy.Anesthesia: 2 mg versed.Gej: 40.Indication: severe obesity, reflux.Hh [hiatal hernia], gastritis.Description of procedure: the patient was taken to the endoscopy suite and placed in the left lateral decubitus position.The above anesthesia was given to the patient intravenous over the course of the procedure.Through the bite block, the scope was placed in the posterior pharynx under direct visualization.The esophagus was intubated and advanced to the gej.The scope was then advanced into the stomach without difficulty.The findings were as above.The scope was then advanced thru the pylorus without difficulty into the first and second portion of the duodenum.The mucosa and ampulla were normal.The scope was then brought back into the antrum and retroflexed.The findings were as above.A biopsy was then performed.The biopsy site was hemostatic therefore the scope was withdrawn from the patient.It was felt that because of her obesity and sleep apnea, that romazicon was used to prevent delayed affects of versed later in day.Recommendations: await biopsy, continue ppi [proton pump inhibitor] helidac, no nsaids [nonsteroidal anti-inflammatory drugs], continue workup for gastric.(b)(6) 2005: (b)(6) medical center.(b)(6) md.Radiology¿ct pelvis w/ contrast.Findings: there is a large ventral hernia with herniation of small bowel loops in the lower mid pelvis.Bowel loops are normal.Impression: large ventral hernia.(b)(6) 2005: (b)(6) llc.(b))(6) md.Pathology.Accession #: (b)(4).Material submitted: 1) panus.2) incisional hernia sac.Clinical diagnosis: incisional hernia repair, panniculectomy.Preoperative diagnosis: same, large panus, pain, obesity, incisional hernia.Final diagnosis: 1) panus: benign skin and adipose tissue.2) incisional hernia sac: hernia sac.Gross description: received in two parts.Each part labeled mary pigg.Part one is designated ¿panus¿.Received is a pink-tan-gray ellipse of skin that measures 17.5 cm x 49.4 cm x 5 cm in greatest dimension with a large underlying fat pad.The specimen is serially sectioned.Representative sections are submitted in cassettes (1, 2, 3).Part two designated as ¿incisional hernia sac¿.Received is a gray-tan-purple to red-brown irregular segment of soft tissue measuring 4.2 x 2.3 cm x 1.5 cm in greatest dimension.The specimen is serially sectioned.Representative sections are submitted in cassette (4).Microscopic description: 1) the tissue labeled ¿panus¿ includes abundant mature, lobulated adipose tissue and benign skin.2) a mesothelial surface epithelium covers fibroadipose tissue.??/??/13: [missing records: an operative report for hernia repair was not provided.] ??/??/14: [missing records: records for the ct of abdomen and pelvis showing ¿right lower quadrant hernia containing cecum with some stranding around the incarcerated bowel¿ were not provided.] 10/24/17: (b)(6) medical center.(b)(6) md.Radiology-ct abdomen/pelvis.Reason for exam: abdominal tenderness, unspecified site.Indications: history of multiple prior hernia surgeries with abdominal pain and tenderness.Impression: extensive abdominal postsurgical findings, including the ventral hernia mesh repair with decreasing size of the seroma or focal fat necrosis/oil cysts in the right abdominal wall.There is no evidence of recurrent bowel containing hernia, bowel obstruction or other acute gastrointestinal tract inflammatory process.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 with corduroy® tissue ingrowth surface 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: health effect impact code: f26: no health consequences or impact.Previous patient code (3190) was reported based on the original complaint and is 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 september 4, 2002 through october 24, 2017 and not all records received in this time span are relevant to the unknown gore® dualmesh® plus biomaterial device.Records from september 11, 2002 through october 6, 2003 were not provided.Patient information: medical history: morbid obesity (b)(6) 2002: 320 lbs; bmi 52, (b)(6) 2003: 312 lbs; bmi 50, (b)(6) 2004: 355 lbs; bmi 57, (b)(6) 2012: 376 lbs; bmi 61, (b)(6) 2014: 423.8 lbs; bmi 68, and (b)(6) 2017: 209 lbs: bmi 33.Prior surgical procedures: 1989, 1991: dilation and curettage.1998: laparoscopic cholecystectomy.2000: laparoscopic roux-en-y gastric bypass.2001: hernia repair.(b)(6) 2001: diagnostic laparotomy.(b)(6) 2001: hysterectomy with bilateral salpingo-oophorectomy.Implant preoperative complaints: (b)(6) 2002: ¿underwent total abdominal hysterectomy approximately 1 year ago.6 months ago started noticing a bulge left of the incision.Became increasingly large and painful.Does not have any obstructive or incarceration symptoms.¿ ¿obese.Gastrointestinal- lower midline incision had a ventral hernia defect to the lateral side of the portion of the incision.Felt to be chronically incarcerated but it was difficult to tell as the patient was quite obese.¿ (b)(6) 2002: [the patient] ¿is a 34 year old white female who previously underwent total abdominal hysterectomy approximately one year ago.Six months ago she began noticing a bulge just to the left of the lower midline incision.It had become increasingly large and more painful.She is admitted at this time for laparoscopic repair.¿ implant procedure: laparoscopic ventral incisional hernia repair with mesh.Implant: gore® dualmesh® plus biomaterial (00751001/1dlmcp06) 18 cm x 24 cm.Implant date: (b)(6) 202002 description of hernia being treated: ¿an infraumbilical incision was made with a #5 blade.The incision was spread with a hemostat and a veress needle was inserted through the fascia and into the peritoneum.Intraperitoneal placement was confirmed with saline drop test.The peritoneum was then insufflated with carbon dioxide.Once an adequate pneumoperitoneum was obtained a 5 mm trocar was placed through the infraumbilical incision.The abdomen was examined.There was indeed a large ventral hernia defect extending from the midline incision to the left lateral side.Two 10 mm trocars were placed in the lateral mid lower abdomen bilaterally.The camera was variously placed in these trocars to discern the extent of the hernia defect.This was marked externally on the skin with a marking pen.¿ implant size and fixation: ¿a piece of dual mesh was then fashioned to adequately cover the defect and fashioned in a circular shape by trimming the edges.Marks were also made on the mesh to coincide with the markings on the anterior abdominal wall to facilitate placement once the mesh was placed in the abdomen.Four stay sutures were placed at the lateral aspect and superior mid inferior aspects of the mesh.The mesh was rolled and inserted through the right lower quadrant trocar site after removing the trocar.The trocar was then placed and the mesh was unfurled.The four stay sutures were brought up through the anterior abdominal wall using an endoclose device.Once all four sutures had been placed they were tied externally.The remainder of the mesh was then tacked down using a protack device.A second 5 mm trocar was placed in the left upper quadrant to adequately visualize the entire hernia defect and the entire mesh.The mesh actually extended over the two lateral lower abdominal trocar sites so that no fascial closure was required there.It also extended above the umbilical trocar site.Once the mesh was in place it adequately covered the defect.The abdomen was then allowed to desufflate.The trocar sites were examined for hemostasis.All trocars were then withdrawn.The abdomen completely desufflated and all skin incisions were closed with running 4-0 monocryl subcuticular sutures.Benzoin, steri-strips and dry sterile dressings were applied.¿ no post-operative records were provided.Explant preoperative complaints: (b)(6) 2003: [the patient] ¿is a 35 year old female who previously underwent laparoscopic ventral abdominal hernia repair.She has developed a recurrent bulge and on ct scan had a recurrent ventral hernia.She is admitted at this time for operative repair.¿ explant procedure: open repair of recurrent ventral hernia with mesh, removal of previous mesh.Explant date: (b)(6) 2003.¿her previous lower midline incision was reopened with a #10 blade.The incision was carried down through the subcutaneous tissue using electrocautery.The hernia sac was identified and dissected out circumferentially using the electrocautery.The sac was entered.The previously placed mesh was removed also using electrocautery and the fascia debrided back to healthy fascial edges.There was also some omental adhesions to the undersurface of the mesh and these were lysed as the mesh was removed.Once the mesh had been completely removed and the fascia debrided, a piece of marlex mesh was used sutured to the undersurface of the fascia using a running #1 prolene sutures.Subcutaneous tissue was irrigated and examined for hemostasis which was found to be adequate.A 10 french flat jackson-pratt drain was placed on top of the fascial repair and brought out through a separate stab incision.The drain was sutured in placed with a 2-0 silk suture.The skin was then closed with staples.A dry sterile dressing was then applied.¿ records indicate a non-gore device was implanted during the (b)(6) 2003 procedure.Relevant medical information: (b)(6) 2003: discharge summary: ¿previously underwent uneventful hernia repair.Developed postoperative fever.Chest x-ray, sinus films, and cbc were normal.Fever subsided spontaneously.Jackson pratt drain in place which had drained 90 cc 24 hours prior to discharge.Incision was healing well at the time of discharge.¿ conclusions: it should be noted that the gore® dualmesh® plus biomaterial instructions for use include 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.¿ 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 above inherent risks are typically detailed in standard informed consent documents.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.Section c1: name: plus antimicrobial product coating manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 00751001.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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