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| Model Number 1420030010 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Abscess (1690); Unspecified Infection (1930); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 05/09/2012 |
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Event Type
Injury
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Manufacturer Narrative
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It should be noted that the gore-tex® soft tissue patch instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore-tex® soft tissue patch instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.
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Event Description
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It was reported to gore that the patient underwent open abdominal hernia repair on (b)(6) 2005 and (b)(6) 2011 whereby a gore-tex® soft tissue patch and a gore® dualmesh® biomaterial were implanted.The complaint alleges that on (b)(6) 2012 and (b)(6) 2013, additional procedures occurred whereby a gore device was explanted.It was reported the patient alleges the following injuries: bowel obstruction, recurrences, multiple lysis of dense adhesions, removal of mesh, bowel perforation, multiple rounds of treating infected mesh with abscesses, mesh migration, and pain and suffering.Additional event specific information was not provided.
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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: implant procedure#1: repair of abdominal hernias with insertion of mesh.Implant: gore-tex® soft-tissue patch [1420030010/03865643] implant #1 date: (b)(6), 2005 (hospitalization ni) ¿ (b)(6) 2005: (b)(6) clinic foundation.(b)(6), md.Operative report.Assit.1: (b)(6), md.Operation: repair of abdominal hernias with insertion of mesh.Anesthesia: general.Preoperative diagnosis: multiple abdominal hernias status post colectomy for crohn¿s disease.Postoperative diagnosis: multiple abdominal hernias status post colectomy for crohn¿s disease.Operative findings: there were multiple holes in the abdominal fascia and muscles with mostly fat or omentum within the holes.Operative procedure: ¿with the patient under general anesthetic, he was placed in the supine position on the operating room table.A foley catheter was placed in the bladder.The abdomen was prepared and draped.It was reopened through the previous midline incision.Attenuated fascia was incised and the peritoneal cavity entered.Minimal adhesions were present.The abdomen was completely reopened and the fascia edges >¿.<.These were quite a way back laterally and out of site.A 20 x 30 cm piece of 1-mm thick gore-tex was used for the repair.This was sewn in placed circumferentially with interrupted >¿.< ti-cron sutures.A satisfactory repair was obtained.The attenuated fascia was then brought together with ti-cron and chromic over the top of the mesh and a jackson-pratt drain was placed through a separate stab wound into the subcutaneous tissues.Subcutaneous tissues were then brought together with chromic and the skin was closed with staples.The patient¿s condition throughout and at the end was satisfactory and stables.¿ counts: sponge, instruments, and needle counts were correct.Estimated blood loss: about 150 cc.Drains: as above.Complications: none.¿ (b)(6) 2005: (b)(6) clinic foundation.Implant sticker.Implant: gore-tex® soft tissue patch.Ref/catalogue number: 1420030010.Lot/batch code: 03865643.Manufacturer: w.L.Gore & associates.¿ the records confirm a gore-tex® soft-tissue patch (1420030010/03865643) was implanted during the procedure.Implant procedure #2/explant procedure #1: complex ventral hernia repair with gore-tex mesh.Excision of mesh and extensive lysis of adhesions.Reduction of at least 3 ventral hernias containing intestine.Implant: gore® dualmesh® biomaterial [1dlmc07/9305910] implant #2 date: (b)(6), 2011 (hospitalization ni) ¿ (b)(6) 2011: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: multiple abdominal ventral hernias with loss of domain and chronic intestinal obstruction.Postoperative diagnosis: multiple abdominal ventral hernias with loss of domain and chronic intestinal obstruction.Procedure: complex ventral hernia repair with gore-tex mesh.Excision of mesh and extensive lysis of adhesions.Reduction of at least 3 ventral hernias containing intestine.Indication: the patient is a 46-year-old male who has had multiple abdominal hernias and repairs the last of which was in 2006 at (b)(6) clinic where he was repaired open with a mesh.He recurred a few months later and has been dealing with these hernias.However, last month he was admitted for partial bowel obstruction and since discharge has continued to have recurring symptoms and has maintained himself in small frequent meals consisting mostly of liquid intakes.He understood the risks of the procedure.However, was unable to continue his nutrition given the obstructive symptoms and chronic pain.Risks included bowel injury, respiratory failure, bleeding, wound infection, mesh infection.Operative procedure: ¿the patient was taken to the operating room and placed supine on the operating room table.After adequate iv sedation, he was intubated and general anesthesia was administered.Preoperative antibiotics were administered.The abdomen was prepped and draped in the standard sterile surgical fashion.A midline incision was started at the xiphoid and eventually carried down through the pubis.The area just below the xiphoid was virgin territory and we were able to identify the fascia and enter the peritoneal cavity without difficulty.We then approached the mesh and layer by layer, we were able to separate the mesh from the peritoneal cavity.We divided the mesh down the middle all the way until the inferior edge of the mesh and until healthy fascia was identified inferiorly.We then lysed adhesions on both sides of the abdominal wall to the mesh all the way down to the retroperitoneum.We then ran the intestines and found multiple adhesions to the small intestine some of which were lysed using sharp dissection.We did have one serosal tear which was likely just scar tissue which was repaired with one 3-0 silk pop-off stitch.We then identified his colon which was intact, transverse colon and descending colon down to rectum as he had had a sigmoid colectomy then.We did identify a mesenteric defect in that area probably as we had lysed adhesions from the abdominal wall.This was repaired using 2-0 vicryl in a running fashion.With the mesenteric defect repair, we placed the intestines back into their anatomic position.We then began by removing the mesh on either side using bovie cautery and metzenbaum scissors.Once the mesh was removed, we resected multiple hernia sacs starting on the left abdominal wall.He had one large 10 x 5 cm sac just above the umbilicus which was the area where it had the chronic partial obstruction that was giving him some discomfort.Prior to removal of the sac, we obviously had reduced the hernias.We then resected the sac and passed this off the table as a specimen as well as the mesh.We then resected a smaller second sac in the inferior left abdominal wall.The peritoneal defect was repaired using #1 maxon and the anterior sheath of the fascia was repaired using #1 prolene in a figure-of-eight fashion.This defect was though the left rectus muscle.We then turned our attention to the right defect which was a gigantic hernia with loss of domain.This contained both colon and small bowel.It measured 20 x 15 cm at least.It admitted at least one of my hands within the defect itself and had a very thin skin flap.We then resected that sac in its entirety and passed it off the table as a specimen.With that done, flaps were created on either side circumferentially until good fascia was obtained.We were unable to reapproximate the rectus muscle given his loss of domain and so a 20 x 30 cm piece of gore-tex mesh was placed.This was secured with mattress sutures in an underlay fashion superiorly, inferiorly and on either side at 3 and 9 o¿clock.We then used the same sutures after securing them to run the mesh in a continuous fashion.The mesh had been trimmed.There were at least 3 cm of overlap and we ensured that the mesh was placed in the correct position with a nonadherent face towards the intestines.After irrigation, we then placed 3 jp drains.The jp drain exiting on the left lower side of the incision is within the left hernia sac and flap.The one on the right side is on the gigantic right hernia defect and the one down the middle is on the superior pole and on the mesh.We then closed the subcutaneous tissues using interrupted figure-of-eight vicryls and separated the mesh form the skin.The skin was closed using staples.The skin was clean dried.The jps were secured in place using 2-0 nylon sutures.Dry sterile dressing was applied followed by 2 binders.The patient tolerated the procedure well and was transported to the recovery room awake, alert, in good condition.The sponge, needle, and instrument counts were correct at the end of the case times two.¿ attestation statement: i was present for the entire procedure and assisted with all key and non-key portions of the procedure.¿ (b)(6) 2011: (b)(6).Implant sticker.Implant: gore dualmesh® biomaterial.Red/catalogue number: 1dlmc07.Lot/batch code: 9305910.Manufacturer: w.L.Gore & associates.¿ the records confirm a gore® dualmesh® biomaterial (1dlmc07/9305910) was implanted during the procedure.Explant procedure #2: excision of scar with staged laparotomy or reduction of ventral hernia and advancement of musculocutaneous flaps (staged procedure).Explant #2 date: (b)(6), 2012 (hospitalization (b)(6), 2012) ¿ (b)(6) 2012: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: ventral hernia.Postoperative diagnosis: ventral hernia.Procedure: excision of scar with staged laparotomy or reduction of ventral hernia and advancement of musculocutaneous flaps (staged procedure).Indications: the patient is a 46-year-old male with history of recurrent ventral hernia status post multiple repairs.Recently at the end of last year, he had a ventral hernia repair with a large piece of gore-tex dual mesh.He had loss of domain at that time and thus could not be repaired primarily by separation of parts.He presented today for partial removal of his mesh and further reduction in size in preparation for future separation of parts.Description of operation: ¿the patient was taken to the operative room and placed supine on the operating room table.After adequate iv sedation, he was intubated and preoperative antibiotics were administered.The abdomen was prepped and draped in a standard sterile surgical fashion.The large midline incision was resected using the knife in an elliptical fashion followed by bovie cautery and the subcutaneous tissues.Hemostasis was obtained.The abdomen was then prepped and draped once again.We then used bovie cautery until we were able to identify the mesh which was then incised using metzenbaum scissors.The mesh was preserved at the rind or peel just above it.It was bluntly dissected and incised.We were then able to identify the mesh which was also incised in the midline until we were able to enter the peritoneal cavity.There were minimal adhesions of the intestines to the mesh.We were able to identify the rind on the inferior aspect of the mesh, and this was lysed bluntly circumferentially until we were able to identify sutures in the left aspect of the mesh and not too much on the right aspect of the mesh.We were able to clear off at least 5 cm on either side as well as all the way to the xiphoid and inferiorly to the edge of the mesh.We then marked an area which was 3 cm to either side of the midline of the mesh.We checked airway pressure by reducing the cavity, and the airway pressures remained intact at 28 to 29.We then resected the mesh circumferentially removing 3 cm from either side.Hemostasis was then obtained.We also removed using bovie cautery the excess superficial rind to healthy subcutaneous tissues circumferentially.Once hemostasis had been obtained, we placed a piece of surgicel at the inferior portion of the intraperitoneal cavity secondary to some oozing from serosa.We then placed seprafilm on top of the intestine and closed the gore-tex over the seprafilm using #1 prolene in a running fashion as well as with 4 interrupted figure-of-eight suture for reinforcement.Once closed, there were good airway pressures about 28 to 29.The wound was irrigated copiously again with antibiotic solution.The subcutaneous tissues were reapproximated using 3-0 vicryl figure-of-eight in interrupted fashion.The skin was closed using staples.A 10 flat jp drain was placed to the subcutaneous tissues and placed to bulb suction and secured with a 2-0 nylon stitch.The skin was clean dried.Dry sterile dressing was applied.The patient tolerated the procedure well and was extubated and transferred to the recovery room awake, alert, and in good condition.The sponge, needle, and instrument counts were correct at the end of the case times two.¿ attestation statement: i was present for the entire procedure and assisted with all key and non-key portions of the procedure.Relevant medical information: ¿ (b)(6) 2012: (b)(6).(b)(6).Operative report.Preoperative diagnosis: abdominal wall abscess with infected prosthetic mesh.Postoperative diagnosis: abdominal wall abscess with infected prosthetic mesh.Procedure performed: incision and drainage of abdominal wall abscess with plication of the existing mesh.Negative pressure dressing application, 24 x 6 cm.Resident: dr.(b)(6).Anesthesia: general endotracheal.Indication: the patient is a 47-year-old man with a long history of abdominal wall hernias with recurrence and mesh placement.He has been managed for mesh infection with debridement, drainage and controlled with antibiotics.He returned to the hospital yesterday with symptoms of abdominal pain and skin changes.Imaging revealed abscess surrounding the existing mesh.Drainage was recommended.Findings: white purulent material approximately 50 ml surrounding mash [sic], most of this fluid was on the anterior surface of the mesh.A smaller volume was posterior to the mesh.Description of procedure: ¿the patient was taken to the operating room and underwent anesthesia without difficulty.His previous midline incision was opened overlying the area of imaging suggesting a fluid collection.Cautery was used for hemostasis.The fluid collection was entered.Copious cream colored fluid was cultured.The wound was opened to the margins of densely adherent mesh to the subcutaneous tissue.This was done both cephalad and caudad and laterally to either side.The previously placed prolene sutures were opened between mesh leaves.This revealed more fluid underneath the mesh.This was not interrogated or breached.Approximately 4 to 5 cm of mesh was able to be mobilized from underlying peel in either direction.Copious antibiotic saline was used to irrigate the wound.Hemostasis was good.Intraoperative consultation with the plastic surgery service was obtained.In coordination with them it was decided that plication of the mesh with negative pressure dressing would be the best temporary management of this problem.The mash [sic] edges were plication approximately 2-3 cm using 0 prolene sutures.Over the approximated mash [sic], negative pressure dressing was applied.The patient was prepared for return to recover.¿ estimated blood loss: 20 ml.Specimen: abdominal wall abscess fluid for culture.Sponge, needle, and instrument counts were reported as correct.I was present for the entire operation.Explant procedure #3: exploratory laparotomy with extensive lysis of adhesions greater than 4 hours (modifier 22 for extreme difficulty), excision of entire infected gore-tex mesh.Right and left rectus abdominis muscle flap advancement, repair of transverse right ventral hernia and repair of midline abdominal wall defect.Explant #3 date: (b)(6), 2013 (hospitalization ni) ¿ (b)(6) 2013: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: infected mesh with ventral hernia.Postoperative diagnosis: infected mesh with ventral hernia.Procedure: exploratory laparotomy with extensive lysis of adhesions greater than 4 hours (modifier 22 for extreme difficulty), excision of entire infected gore-tex mesh.Assistant: (b)(6), md.Indication: mr.(b)(6) is a 48-year-old male who has a longstanding history of recurrent incisional hernias with currently an infected mesh.He initially presented with multiple hernias, treated with a skin-only closure and loss of domain.He subsequently required multiple reductions of his gore-tex mesh until we have been finally able to hopefully now put him back together with separation of parts by dr.(b)(6) of plastic surgery.Operative procedure: ¿the patient was taken to the operating room, placed supine on the operating room and after adequate iv sedation, he was intubated and general anesthesia was administered.Preoperative antibiotics were administered.The abdomen was prepped and draped in a standard sterile surgical fashion.The previous jackson-pratt drains were removed.We then made a midline incision from xiphoid to pubis and carried down through the subcutaneous tissues.The scar tissue was carefully dissected with care to avoid any inadvertent enterotomies or bowel injury.We were able to eventually reach the plane of the mesh.We slowly cut the stitches from the mesh and were able to piece by piece be able to excise the mesh circumferentially in its entirety using sharp and blunt dissection with metzenbaum scissors.Once we did this, we had very little room within the abdomen as there were still a rind inferior to the mesh and significant purulence adjacent to the peritoneum.After all of this was cleaned off, we were slowly able to enter the actual peritoneal cavity at the xiphoid.We painstakingly when [sic] across the entire abdomen loosening the mesh reaction form the peritoneum circumferentially.Care was taken once again not to injure the bowel.This took over 4 hours to dissect circumferentially using metzenbaum scissors.Once this was completely done and freed out, we had more than 2 inches on either side from the edge of the fascia to adhesion tissue.There were adequate hemostasis.The abdomen was irrigated copiously until clear.Both previous jp sites were excised in elliptical fashion and the drain site curetted.There were multiple small swiss cheese hernia from where the mesh had been tacked to the fascia.In fact, initially, the right aspect of the mesh had been almost completely pulled off on the right side of the fascia for approximately 5 cm.Once everything was nice and clear, i had dr.(b)(6) and his team come into the operating room to begin their portion of the procedure.The sponge and instrument counts were correct on the case x2.We will, however, obtain closure films as there were 2 services involved.I was present for all key portions of my portion of the procedure as well as non-key portions and scrubbed for the entirety of my portion of the case.Once the abdomen was closed with a component separation and skin closure and jps, he was taken to the recovery room in stable condition.¿ ¿ (b)(6) 2013: (b)(6).(b)(6), md.Operative report.Preoperative diagnosis: multiple large ventral hernia, morbid obesity, diabetes mellitus, prior history of abdominal infection, personal history of multiple prior abdominal operations.Postoperative diagnosis: multiple large ventral hernia, morbid obesity, diabetes mellitus, prior history of abdominal infection, personal history of multiple prior abdominal operations.Procedure performed: right and left rectus abdominis muscle flap advancement, repair of transverse right ventral hernia and repair of midline abdominal wall defect.Anesthesia: general.Indication: (b)(6) is an unfortunate 48-year-old gentleman who has a complex abdominal wall defect.Dr.(b)(6) had removed his existing mesh, lysed all adhesions.For detail, please refer to her operative report.Description of procedure: ¿attention was then turned to the abdomen where his inflammatory rind and hernia sac were dissected free from the abdominal wall, identifying markedly laterally displaced rectus abdominis muscle with swiss cheese type hernia defects along the midline ventral components.He also had a broad base 6 x 12-cm mid abdominal right transverse weakness in which his entire rectus fascia to the transversalis was attenuated.This was dissected of old chronic inflammatory tissue, and then, a complex repair of the internal and external fascia as then accomplished with #1 prolene.Attention was then turned along the rectus abdominis muscle, which was then released along the lateral portion above the level of the rib cage for approximately two-thirds of its length and dissection then carried along the external oblique muscle, releasing this and advancing the muscle flaps forward.This was done first on the patient¿s right side and then on the patient¿s left side, mobilizing the fascial edges to meet at the midline under minimal tension.Muscle flaps were then inset with #1 prolene.Homeostasis was maintained with meticulous electrocautery.Sponge, lap and instrument counts were correct x3 and were verified by x-ray.Three 10-mm blake drains were placed.Hemostasis was maintained with 2-0 and 3-0 silk suture ligatures and electrocautery.The wounds were irrigated with copious amounts of bacitracin-impregnated solution prior to closure.All scar tissue, hernia sac was excised along this 35-cm incision prior to closure, and a 3-layer plastic closure was then accomplished.The patient tolerated the procedure well.There were no intraoperative or immediate postop complications.¿ estimated blood loss: for our portion of the operation was less than 200 ml.Attestation statement: i, dr.(b)(6), was present for and performed the operation.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-tex® soft tissue patch instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore-tex® soft tissue patch instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore-tex® soft tissue patch instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore-tex® soft tissue patch instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.Through gore's investigation and based on the available information 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.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore-tex® soft-tissue patch 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: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ 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.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.Review of the manufacturing and sterilization records verified that the lot met all pre-release specifications.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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Search Alerts/Recalls
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