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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: (b)(6) 09: (b)(6) hospital.(b)(6), md.History and physical.Chief complaint: ¿¿who enters now for repair of a ventral incisional hernia.History of present illness: ¿¿ who has a prior history of multiple abdominal surgeries including an exploratory laparotomy for trauma and a cholecystectomy.The patient has gone on to develop a bulge in the epigastrium.The bulge is now rapidly increasing in size with the patient initially noticing a bulge 6 months ago.With the increase in size, she occasionally notes nausea without vomiting.The patient also notes discomfort with exertion.A focused physical examination of the abdomen demonstrates multiple healed incisions.She does have evidence of the hernia in the epigastrium with the contents being reducible.There is no tenderness, guarding, rebound, nor masses appreciated.¿ impression and plan: ¿ventral incisional hernia.Plan: the patient will be carried to the operating room for repair.¿ (b)(6) 09: (b)(6) hospital.(b)(6), md.Indications: ¿¿ who presents now having a history of multiple surgical procedures in the past.Included in her surgeries has been a trauma laparotomy.She has also undergone cholecystectomy.The patient has multiple abdominal incisions.She has gone on to develop a ventral incisional hernia in the epigastrium.This hernia is increasing in size and causing her discomfort.The patient will now be carried to the operating room for repair.¿.Implant procedure: laparoscopic-assisted ventral incisional hernia repair.[implant: gore® dualmesh® plus biomaterial, 1dlmcp06/no information, 18cm x 24cm x 1mm.].Implant date: (b)(6), 2009 [hospitalization (b)(6), 2009].(b)(6) 09: [incorrectly documented as (b)(6) 09] (b)(6) hospital.(b)(6), md.Operative report.Preoperative and postoperative diagnosis: ventral incisional hernia.Anesthesia: general.Pathology specimens: hernia sac.Wound class: ¿clean¿.Procedure: ¿attention was turned to the midline.An upper midline incision was made.The skin and subcutaneous tissues were penetrated using sharp dissection with hemostasis obtained using electrocautery.The abdomen was then entered through the midline fascia.The patient was noted to have multiple hernia defects along her entire midline incision.The abdomen was entered and the midline opened from the level of the xiphoid to the level of the umbilicus.Omental adhesions were then encountered and these were taken down.With all of the omental adhesions taken down, four 5-mm trocars were placed under direct vision, two on each side of the abdomen.A 24-cm x 14-cm dual-mesh patch was then prepared.Sutures were placed on the midportion of each side of the patch.The patch was then introduced into the abdomen.Four sutures were then placed through the abdominal wall using the suture passer.With the patch seated within the abdomen, attention was then turned to the midline fascia.The midline fascia was closed using 2 running double-stranded pds sutures.The wound was irrigated and the skin was closed using skin staples.A pneumoperitoneum was then established.A forward-viewing, 0-degree, 5-mm laparoscope was then advanced into the abdomen.The entire perimeter of the patch was then secured to the abdominal wall using approximately 80 us surgical tacks.Two additional sutures were then placed superiorly on the corners of the patch just below the ribs on each side.Ultimately, the patch was secured in place using a total of 80 tacks and 6 sutures.Satisfied with this repair, the small bowel was inspected with no enterotomies noted.There was no evidence of bleeding.Satisfied with the procedure, the pneumoperitoneum was evacuated and the trocars were removed.The wounds were closed using interrupted 5-0 monocryl suture.Sterile dressings were applied.¿ (b)(6) 09: (b)(6) hospital.Implant record.Description: ¿dual mesh plus patch.¿ lot number: ¿1dlmcp06¿.Catalog no: ¿n/a¿.Manufacturer: gore.Implant site: abdomen.Quantity: 1.Size: ¿18cm x 19 cm.¿ expiration date: 7/1/11.(b)(6) 09: (b)(6) hospital.(b)(6), md.Discharge summary.¿her postoperative course initially was remarkable for pain and nausea.Her pain was managed with iv analgesia and her nausea antiemetics.(b)(6) otherwise has done well postoperatively.She is ready for discharge with followup appointments in the office as an outpatient.¿ final diagnosis: ventral incisional hernia.Relevant medical information: [not indicated].Revision preoperative complaints: (b)(6) 13: (b)(6) hospital.(b)(6), md.Radiology.Ct abdomen and pelvis.Indication: abdominal pain.¿there is a moderate hiatal hernia.There are surgical changes in the anterior abdominal wall.The gallbladder is removed.There is small bowel dilatation filled with fluid and air.The colon is decompressed.There is evidence of diverticulosis without acute inflammatory change.The appendix is within normal limits.There is no free air.¿ ct pelvis: ¿there is no definite abdominal or pelvic lymphadenopathy.¿ impression: ¿findings compatible with small bowel obstruction.¿ (b)(6) 13: (b)(6) hospital.(b)(6), md.History and physical.Presented with complaints of nausea, vomiting and abdominal pain for a month.Pain is like a ¿stitch in her side¿ and located on right lower lateral abdomen.Off and on crampy.Came to emergency room on (b)(6) 13 and was diagnosed with opioid withdrawal and chronic back pain.Yesterday right lower quadrant pain recurred but stayed this time and began radiating across left lower quadrant.Continues with nausea and vomiting and has been able to keep very little by mouth.Lost about 25 pounds since 6/10.Last bowel movement yesterday described as small and black.Current medications include plavix, prevacid and promethazine.History of hypertension, chronic pain, gastritis, anxiety, hyperlipidemia.Surgical history of trauma laparotomy 1986.Weight 73.8 kg.Exam: normal bowel sounds, very mild distention.Soft but with voluntary guarding in the lower quadrants.At one point she was distracted and i was able to palpate the abdomen without and guarding; no rebound.Has ice pack on lower abdomen.Ct scan of abdomen and pelvis without contrast: small bowel is mod dilated and fluid filled down to ileus which appears decompressed distally.Colon is also decompressed but does have bits of stool and air in it.A large ventral mesh with numerous metal tacks is noted.Documentation reviewed: patient¿s cerner record was reviewed.Operative report form dr.(b)(6) in 2009 indicated she had a 24 cm x 14 cm piece of dual-mesh placed and secured with protacks.She has had several admissions for chest pain since at least 2006; well known.Impression/plan: intestinal obstruction, acute hypokalemia, abdominal pain, anemia.Oral potassium.Nasogastric tube to be placed in emergency room.She has large anterior dual-mesh in place which will increase the complexity of any abdominal surgery.Therefore will trial conservative therapy with nasogastric tube decompression and bowel rest.(b)(6) 13: (b)(6) hospital.(b)(6), md.Radiology.X-ray abdomen flat and erect.Indication: follow up small bowel obstruction.Findings: ¿there are surgical changes throughout the anterior abdominal wall.¿ impression: ¿high position of the nasogastric tube tip.The bowel gas pattern shows no evidence of intestinal obstruction or free air.¿ (b)(6) 13: (b)(6) hospital.(b)(6), md.Radiology.X-ray abdomen.Findings: ¿single ap view of the abdomen and pelvis shows persistent dilatation of the small bowel 21.5 hours after the start of the study.No contrast is seen in the colon.The ng tube is in the stomach.Small bowel obstruction or ileus are suspected.¿ (b)(6) 13: (b)(6) hospital.(b)(6), md.Radiology.Upper gi and small bowel series.Indication: nausea and vomiting, plain film nad, abdominal pain.Upper gi: findings: ¿there is orogastric/nasogastric tube in the stomach.Contrast is seen to outline the stomach and proximal small bowel.Contrast is seen to promptly go into the small bowel.¿ impression: no evidence for gastric outlet obstruction.Small bowel series: findings: ¿the small bowel is dilated and there is very slow transit time.The study was extended up to 9 hours after the administration of the oral contrast.However, no colonic activity is seen at 9 hours.¿ impression: ¿ileus versus small bowel obstruction with delayed transit time.¿ (b)(6) 13: (b)(6) hospital.(b)(6), md.Radiology.Follow up small bowel series.Findings: ¿single ap view of the abdomen and pelvis shows persistent dilatation of the small bowel 21.5 hours after the start of the study.No contrast is seen in the colon.The ng tube is in the stomach.Small bowel obstruction or ileus are suspected.¿ (b)(6) 13: (b)(6) hospital.(b)(6), md.Indications: ¿this is a 70-year-old white female who is status post multiple abdominal surgeries the last being repair of a large ventral hernia with dual mesh and pro-tacks.She was admitted 4 days ago with symptoms of small bowel obstruction.She has undergone ng tube decompression, bowel rest, and serial abdominal exams.She has also had a small bowel follow-through.Despite these conservative efforts, she has had no bowel movement or flatus and the small bowel follow-through shows no passage of the contrast beyond a point in the lower abdomen.She was advised of the need for exploratory laparotomy with possible bowel resection.In the presence of the prosthetic mesh, if bowel is resected, the mesh would then have to be removed as well and replaced with a biologic.It was also recommended to place a central line for administration of total parenteral nutrition postoperatively.The risks were explained and included but were not limited to bleeding, infection, bowel injury, and recurrent adhesions and risk for future bowel obstructions.She expressed understanding and signed consent for the procedure.She had been receiving levaquin since her admission.Scds were applied for dvt prophylaxis.¿ revision procedure: extensive adhesiolysis, insertion of right internal jugular central line, incidental appendectomy.Revision date: (b)(6), 2013 [hospitalization (b)(6), 2013 ¿ (b)(6), 2013].(b)(6) 13: (b)(6) hospital.(b)(6), md.Operative report.Assistant: (b)(6), rnfa.Preoperative diagnosis: small bowel obstruction.Postoperative diagnosis: small bowel obstruction due to adhesion to prosthetic mesh and tacks.Anesthesia: general.Specimen: normal appendix.Findings: ¿diffuse adhesions between entire mesh and omentum.Portion of small bowel adherent to several metal tacks in llq [left lower quadrant] creating a single kink in bowel.¿ procedure: ¿patient was brought to the operating room and placed supine on the operating room table with the arms extended out laterally.Once general anesthesia was established and the airway secured, the right neck and chest were prepped and draped in standard surgical fashion.A time out was performed confirming the correct patient and procedure.A quad-lumen central catheter was then placed in the right ij using standard technique.The vein was identified and confirmed via flashback using a large bore needle.A wire was inserted and using seldinger technique the tract was dilated and the catheter placed.Each of the lumens was aspirated and then flushed with normal saline.The catheter was sutured in place.The site was dressed with dry sterile dressing and tegaderm.The catheter was used immediately throughout the case.The abdomen was then fully exposed, widely prepped, and draped in standard surgical fashion.A midline scar was identified and the skin was incised sharply through this same scar from the upper to lower mid line.The subcutaneous tissue was further incised with electrocautery.Once the fascia was identified, suture material was removed while dividing the fascia.As the fascia was divided the dual mesh underneath was encountered.This was carefully opened to allow entry into the abdominal cavity.There were dense adhesions to the internal aspect of the mesh.The majority of these appeared to be omental adhesions.The omental tissue was therefore divided to allow further division of the mesh and opening of the abdomen.Once the abdominal wall was opened enough for inspection there was noted to be omental adhesions across the entire surface of the mesh.This essentially formed a tent-like covering and precluded visualization and palpation of the small bowel.We then proceeded with lysis of these adhesions off of the mesh.There were adhesions between the colon, small bowel, and omentum as well which were taken down.This was performed on both sides of the abdomen to fully expose the bowel.The mesh was noted to be quite intact without any evidence of rolled edges or peripheral defects.Numerous metallic pro-tacks were identified.Those that were directly involved with adhesions to or nearby bowel were removed and passed off the operative field.After about 75 minutes of adhesiolysis we came across a loop of bowel that was fairly distended and mildly inflamed.Tracing this distally it was found to be densely adherent to the left lower corner of the mesh.Extreme care was taken to divide the adhesions between this loop of bowel and the mesh.It became apparent that there were several tacks involved in the adhesions to this loop of bowel.These were removed and passed off.Ultimately the adhesions were divided and the loop of bowel was freed exposing the distal decompressed and uninflamed small bowel.At this point we continued with enterolysis of the proximal small bowel of which there was only mild amounts.Once the proximal small bowel was completely freed it was run up to the ligament of treitz.Some milking of the enteric contents was done and evacuated through the ng tube.We then proceeded to examine the remainder of the bowel.In the right lower quadrant the cecum was found to be normal in appearance with a freely mobile normal appearing appendix.Because of the extent of her adhesions, i elected to remove the appendix.The cecum and appendix were mobilized to allow elevation into the abdominal wound.It was then surrounded by surgical towels.The mesoappendix was clamped and divided and ligated with silk ties.The base of the appendix was then double ligated using o silk ties.The appendix was crossclamped and divided using electrocautery to sterilize the exposed surface.The appendix and all instruments used were passed off the operative field.The stump of the appendix was further cauterized for destruction of the exposed mucosa as well as sterilization.The surgical towels and any lap pads used were then removed and passed off the operative field.I then changed my over gloves and we proceeded with the remainder of the operation.Examining the bowel distal to the point of adhesion and obstruction, the small bowel was found to be adherent to each other diffusely, however the adhesions were soft and moderately thin.As previously mentioned this bowel was decompressed, normal in color and texture.Having clearly identified the point of obstruction i chose not to divide the adhesions between the normal decompressed bowel since this would in site further adhesions postoperatively.In order to test this distal bowel for patency however, i milked some of the proximal enteric contents downward into the distal loops of bowel and observed the response.The small bowel was seen to fill with the succus and began peristalsing quite readily.After examining the remainder of the abdomen for hemostasis and irrigation, it could be seen that this distal small bowel was even further moving the enteric contents through.At this point having examined all of the bowel and finding only the 1 point of obstruction which was relieved with lysis of adhesions, the abdominal cavity was examined for hemostasis which was obtained with electrocautery.It was then irrigated with normal saline.The portion of bowel involved in the adhesions and point of obstruction was examined.The serosa was intact.Satisfied with the procedure we then prepared for closure of the abdomen.3 sheets of seprafilm were placed on the surface of the bowel.The mesh and fascia were then closed with a #1 prolene in a running locking fashion.The suture was placed such that the edges of the mesh were everted to prevent exposure of the marlex side to the underlying bowel.The wound was then irrigated a final time before closing the skin with surgical staples.The wound was then dressed with xeroform gauze, dry sterile dressings, and medi-pore tape.The patient tolerated the procedure well.¿ (b)(6) 13: (b)(6) hospital.(b)(6), md.Pathology.Specimen: appendix.History: small bowel obstruction, adhesion, incidental appendix.Gross description: ¿ ¿¿appendix¿" consists of an appendix with adherent mesoappendix measuring 9.5 x 1.0 x 0.6 cm.A portion of mesoappendical fat measures 3.0 x 1.0 x 0.8 cm and is unremarkable.The sersoal [sic] surface is tan pink, shiny, and mildly congested.Sectioning reveals a mildly distended lumen filled with fecal material.¿ final diagnosis: ¿appendix with no specific pathologic change.¿ (b)(6) 13: (b)(6) hospital.(b)(6), md.Radiology.X-ray abdomen flat and erect.Bowel: ¿the bowel gas pattern is unremarkable.No free air is evident.There is some contrast in the colon.¿ impression: unremarkable chest and abdominal x-rays.(b)(6) 13: (b)(6) hospital.(b)(6), md.Radiology.X-ray abdomen flat and erect.Contrast noted throughout colon.Mild air-filled prominence of small bowel loops in the upper abdomen.Surgical staples noted with surgical clip in left upper abdomen.Cholecystectomy clips also noted.No definite obstructive pattern however is seen and there is no free air.¿ (b)(6) 13: (b)(6) hospital.(b)(6), md.Discharge summary.Admit date: (b)(6) 13.Discharge date: (b)(6) 13.Admitting diagnosis: vomiting, abdominal pain, small bowel obstruction.Discharge diagnosis: small bowel obstruction, postoperative ileus.Operations and procedures: exploratory laparotomy with lysis of adhesions, incidental appendectomy.Hospital course: presented to emergency room with abdominal pain, nausea and vomiting.Symptoms going on over 3 weeks.Ct scan had evidence of a small bowel obstruction.Also had a large ventral mesh with numerous tacks in place.Patient was admitted for conservative management based on presumption that her obstruction is adhesive in nature.A nasogastric tube was placed on low wall suction and she was started on intravenous fluids.On hospital day 2 she was started on clinimix due to report she had not been eating more than applesauce and crackers for last month.Had high output on nasogastric tube and no evidence of bowel function returned and therefore on (b)(6) she was taken to the operating room for exploratory laparotomy.Postoperatively patient had prolonged ileus as expected.Started on total parenteral nutrition.Continued with nasogastric tube decompression.On post-operative day #7 she was started on clear liquids after demonstrating return of bowel function and tolerance of nasogastric being clamped for 48 hours.Has since been advanced to regular diet and is doing well.Moving her bowels daily.Had nausea and vomiting yesterday which she believes is due to narcotic withdrawal.Today she has no symptoms.She is afebrile with stable vital signs and normal white count.Accepted to lifecare at lofland park where she will be transferred to this afternoon.Explant preoperative complaints: (b)(6) 17: (b)(6).(b)(6), md.Indications.¿this is a 74-year-old female with a history of a laparoscopic hernia as well as multiple open hernia repairs.The patient had a persistently draining small bowel fistula on the anterior aspect of her abdomen and it was believed that the patient had a fistula to the previously placed mesh.In addition, the patient had diastasis of her midline as well as a large ventral hernia near the xiphoid.The patient had preoperative optimization and was scheduled for a ventral hernia repair with component separation and explantation of mesh.¿ explant procedure: 1.Exploratory laparotomy.2.Explant of gore-tex mesh.3.Repair of recurrent ventral hernia with 30 x30 cm mesh.4.Extensive enterolysis.5.Small bowel resection.6.Abdominal wall debridement.7.Bilateral posterior component separation with transverse abdominis release and myocutaneous flap.8.Bilateral inferior epigastric flap.9.Placement of on-q catheters.[implant: bard soft mesh.] explant date: (b)(6) 2017 [hospitalization dates not provided.] (b)(6) 17: (b)(6).(b)(6), md.Operative report.Cosurgeon: (b)(6), md.Assistant: (b)(6), md.Preoperative diagnosis: small bowel fistula/ventral hernia.Postoperative diagnosis: small bowel fistula/ventral hernia.Anesthesia: general.Estimated blood loss: 350 ml.Wound classification: not provided.Findings: ¿upon entry into the abdominal cavity, the patient had a previously placed gore-tex mesh with chronic infection and pseudocapsule formation.This mesh was removed along with numerous metallic tacks that were present.The patient required significant enterolysis in order to free up the small bowel which was adhered to the mesh.A segmental small bowel resection was performed of about 50 cm of small bowel with a stapled side-to-side anastomosis.The abdominal wall was debrided and a posterior component separation was performed and a 30 x 30 polypropylene mesh was used in a retrorectus fashion.¿ procedure: ¿the patient was identified in the prep and hold.Consent was verified.The patient was taken to the operating room.General anesthesia was induced.The abdomen was sterilely prepped and draped in the usual fashion.An elliptical midline incision was made which encompassed the previous scar and a knife and electrocautery were used to cut down through the skin and subcutaneous tissue until the anterior fascia was visualized.We then fully excised this elliptical segment of skin.The midline fascia was divided high near the xiphoid and entry into the abdominal cavity was obtained.Using blunt dissection, we were able to push the small bowel down and enter the preperitoneal plane and the midline fascia was divided; however, there were dense adhesions to both aspects of the fascia.The fascia was elevated with kocher clamps and metzenbaum scissors were used to lyse small bowel adhesions off of the previous gore-tex mesh.There was an area of small bowel which adhered to the gore-tex mass causing a small bowel fistula.We then completely removed the gore-tex mesh from the bilateral fascia using blunt dissection and cut out numerous permanent sutures and large metallic tacks which were removed.There was a chronically infected abscess cavity within the gore-tex mesh.Once the gore-tex mesh had been completely removed, we then fully opened the midline fascia.The omentum was serially adhered to the small bowel and draped down into the pelvis significant enterolysis was used to remove the omentum up off of the small bowel and colon and to separate multiple interloop adhesions.There were 2 large enterotomies that were present and after the adhesiolysis had been performed, these were segmentally resected with a gia-75 stapler in 1 continuous 50-cm segment of small bowel.The remaining 2 ends were elevated with allis clamps and a stapled side-to-side functional end-to-end anastomosis was performed with a gia-55 stapler and a ta 90 was used to close the common enterotomy.We then performed extensive adhesiolysis in order to free up the lateral abdominal wall in order to perform bilateral component separation.Once this was done, the abdomen was thoroughly irrigated.We then performed the component separation.Before doing this, the abdominal wall diastasis in the midline was debrided and a portion of the diastasis and chronically thickened scar tissue was excised.The rectus muscle was identified on both sides and bilaterally the posterior fascia was released from the rectus muscle until the transversus abdominis muscle was exposed.The neurovascular bundle to the abdominal wall was preserved and a perforating sparing technique was used to completely release the transverse abdominis muscle bilaterally, superiorly and inferiorly and out to the retroperitoneal space that was placed, to connect the subxiphoid plane exposing the central tendon of the diaphragm.Additionally, inferiorly, we were able to expose the space of retzius and connect both sides of dissection.We then repaired multiple holes in the posterior sheath using a running 0 vicryl and the posterior sheath was closed in the midline using a 0 vicryl suture from the superior and inferior aspect of the incision.Once this was done, we were ready to place our mesh.We sized a 30 x 30 cm polypropylene mesh and cut it in a diamond fashion.This was anchored superiorly to the xiphoid and inferiorly to the pubis using 0 pds suture.The mesh was then anchored laterally using a pds suture to the anterior fascia.Excess mesh was then trimmed.The mesh was completely in the retrorectus space.We then closed the midline abdominal fascia using 0-looped pds in the superior and inferior aspect of the incision.Before doing this, we placed 2 on-q catheters directly over the mesh and underneath the rectus muscle as well as two 19-blake drains.A smaller drain was used in the subcutaneous space.Once the midline fascia was closed, we thoroughly irrigated the wound and the wound was closed with 2-0 stratafix in a deep dermal layer and the 2nd monocryl suture to close subcutaneous tissue.The jp bulbs were hooked to suction and the on-q catheters were instilled with the appropriate anesthetic.Dermabond was used to close the skin.Sterile dressings were applied and the patient was successfully extubated and taken to pacu in stable condition.All instrument counts were correct.Dr.Conway and zabel were present for the entire duration of the case.¿ (b)(6) 17: (b)(6).Implant sticker.¿bard soft mesh.¿.The investigation has been completed.Based upon the totality of the information received over the course of the investigation the following conclusions have been reached.All pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.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.¿ the instructions for use further warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the device.¿ the instructions for use further warn: ¿when using this device as a permanent implant and exposure occurs, treat to avoid contamination, or device removal may be necessary.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.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.After multiple requests, specific lot number information was not provided for this device, but product type has been confirmed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.C1: 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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