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| Model Number 1DLMC04 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Hernia (2240); No Code Available (3191); Insufficient Information (4580)
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| Event Date 01/03/2007 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant #1 preoperative complaints: (b)(6) 2005: (b)(6) health facility.(b)(6) md.History and physical.Previous ovarian cancer, detected during early pregnancy, continued pregnancy, had cesarean delivery and radical hysterectomy.Hernia has been increasingly symptomatic.Admitted for repair.Abdominal pain secondary to hernia.Physical exam: abdomen: long midline hernia present, periumbilical and lower.Impression: ventral incisional hernia, lower midline.Plan: repair.Implant #1 procedure: repair of incisional hernia.Implant: gore® dualmesh® biomaterial [1dlmc02/03496189] implant #1 date: (b)(6) 2005 (hospitalization (b)(6) 2005).On (b)(6) 2005: (b)(6) health facility.(b)(6) md.Operative report.Preoperative and postoperative diagnosis: incisional hernia.Anesthesia: general.Estimated blood loss: less than 100 ml.Specimens removed: skin.Findings: large defects.Procedure: ¿after satisfactory general anesthesia had been obtained, the patient was adequately prepped and draped in usual sterile fashion.Previous midline incision was excised and extended slightly.There was a defect at the umbilical area and a weakening over.We decided to open up the entire fascia and replace it.This was accomplished both by sharp and blunt dissection.We dissected the peritoneum away from this so we could have easy access to the fascia layers.We placed a dual-layer mesh and sew it to the back wall of fascia with running 0 prolene suture.Once this had been completed, we then loosely approximated the fascial edges with a running 0 vicryl suture.Wound was thoroughly irrigated of subcutaneous tissue.We had a jp drain placed through a separate stab wound and sutured in place.The subcutaneous tissue then loosely approximated with 3-0 vicryl and skin closed with staples.Dressings were applied.The patient appeared to tolerate the procedure well.Prognosis for recovery is good.¿ on (b)(6) 2005: (b)(6) health facility.Implant sticker.¿gore dualmesh® biomaterial.¿ ref catalogue number: 1dlmc02.Lot batch code: 03496189.W.L.Gore & associates.On (b)(6) 2005: (b)(6) health facility.(b)(6) md.Pathology.¿received in formalin is an ellipse of skin with underlying adipose tissue.The specimen measures 14 x 1 cm.In greatest dimensions.There is 4 cm.Of underlying adipose tissue.In the center of the ellipse of skin is a well-healed scar.Diagnosis: scar of skin.¿ on (b)(6) 2005: (b)(6) health facility.(b)(6) md.Discharge summary.¿this is a (b)(6) year-old female who has had problems with recurrent ventral hernia through a previous pfannenstiel incision.She was brought into the hospital on (b)(6) 2005, for repair of this hernia, and it was a very significant defect, and we did use mesh to help repair this.Following surgery, she has a small jackson-pratt left underneath the skin.She did reasonably well, and had drainage that was expected for first day or so.The patient did reasonably well and was able to be out and eating and had her drain pulled on (b)(6) 2005, and later that same day, the patient was doing pretty well, and wanted to be discharged to home.I felt at that time it was probably safe to do that.At the time of discharge, we instructed on wound care which was bathe or shower daily and apply a dry dressing.¿ follow up in 7-10 days.Relevant medical information: no information.Implant #2, explant #1 preoperative complaints: (b)(6) 2005: ada cah.(b)(6) md.Abbreviated history and physical.Positive abdominal pain.Physical exam: abdomen: abnormal pain ¿ possible hernia.Assessment: incisional hernia.Plan: exploration and repair.Implant #2, explant #1 procedure: repair of recurrent ventral hernia.Incidental appendectomy.Implant: gore® dualmesh® biomaterial [1dlmc04/03389651].Implant #2, explant #1 date: (b)(6) 2005 (hospitalization dates unknown).On (b)(6) 2005: (b)(6) health facility.(b)(6) md.Operative report.Preoperative and postoperative diagnosis: recurrent ventral hernia.Anesthesia: general.Specimens removed: skin, subcutaneous, old mesh.Drains: jp.Estimated blood loss: approximately 200 cc.Findings: ventral hernia.Procedure: ¿after satisfactory general anesthesia had been obtained, the patient's abdomen was prepped and draped in usual sterile fashion.Hernia defect appeared to be in the lower portion of the incision.We excised the old incision with a fair amount of surrounding subcutaneous fat to get down to this.There was obvious mesh, we pulled out of the patient's right side but it appeared to still be somewhat secure on the left side.We freed this up as best possible and actually excised it being very careful not to injure the underlying bowel.Freed up some adhesions in the bowel and then got ready to be able to place a new piece of dual-layer mesh.We placed the new layer underneath the fascia using 0 prolene and sewed in place.This was a very satisfactory closure.We put it back far enough from the edges that after we had completed this, we could take a #1 pds and closed the fascia! edges over this.We then rinsed this area again and then did closure of the subcutaneous tissue with a jp drain in place entering through a separate stab wound.Drain was secured with a 2-0 nylon.Once the subcutaneous tissue was loosely approximated, we closed the skin with staples.We placed dressings and tape on this and then a binder.The patient appeared to tolerate the procedure well, but this is a big procedure and the chance of recurrence is high.Prognosis for recovery at this time is good.Estimated blood loss for the procedure was 200 ml.¿ ¿because of the multiple surgeries this patient has undergone and the problem she had with the surgery and the fact that we now were trying to secure the abdomen as best possible, i felt that it was in the patient's best interest to first go ahead and remove her appendix at this time.It was easily visible and the cecum was easily brought through the incision.Mesoappendix was sterilely clamped, divided, and tied with 3-0 vicryl.The base of the appendix was crushed and tied with 3-0 vicryl.The appendix was then amputated and the stump tied with 3-0 vicryl.The stump was then inverted and 2-0 silk pursestring in the cecum.Additional 2-0 silk placed above that.There was no blood loss for this portion of the procedure.This course of procedure did not contaminate any other portion of the procedure.We felt that by doing this, we were perhaps preventing the patient from having trouble in the future.¿ on (b)(6) 2005: (b)(6) health facility.Implant sticker.¿dualmesh biomaterial¿.Lot: 03389651.Item: 1dlmc04.On (b)(6) 2005: (b)(6) pathology assoc., inc.(b)(6), md.Surgical pathology.Source of specimen: ventral hernia sac.Appendix.Gross description: received in formalin is an elliptical pouch-like structure composed of fat and connective tissue.The specimen measures 15 x 9 x 2.4 cm.In greatest dimensions.One side of the specimen is smooth and glistening.Received in formalin is an appendix with attached mesoappendix which measures 6.2 cm.In length.The serosal surface is smooth.The distal tip appears fibrosed.Diagnosis: ventral hernia sac.Vermiform appendix.Comment: ¿on the #1 specimen, a foreign body granuloma is noted.It most likely contains suture material.¿ relevant medical information: (b)(6) 2006: (b)(6) health facility.(b)(6) md.Operative report.Preoperative diagnosis: reflux esophagitis and abdominal wall defect.Postoperative diagnosis: large hiatal hernia.Esophagogastroduodenoscop.Abdominal wall hernia repair cancelled to try medicine just for hiatal hernia.¿i made the decision that i am not to fix abdominal wall hernia.Fixing the abdominal hernia at this time would increase the abdominal wall pressure and make the reflux even worse.I think it would be best to treat the reflux for a period of time to see how the patient did and to rule out the possibility of doing a hiatal hernia repair prior to fixing the abdominal wall defect.The patient had been cautioned about this preoperatively.¿ implant #3 preoperative complaints: (b)(6) 2006: (b)(6) health facility.(b)(6) md.History and physical.Previous ovarian cancer while pregnant - has had hernias - low to mid abdomen- now with upper abdominal hernia or weakness.Chief complaint: follow up hernia.History of present illness: bulge and pain in abdomen, reflux, nausea when bending over.Egd recently, ? hernia, not confirmed with ugi.Pain 4/10.Physical exam: abdomen: abnormal weak upper abdomen.Assessment: ventral hernia, reflux and symptoms of hiatal hernia.Plan: repair of ventral hernia.Implant #3 procedure: ventral hernia repair with mesh.Implant: gore® dualmesh® biomaterial [1dlmc04/04495426].Implant #3 date: (b)(6) 2007 (hospitalization (b)(6) 2007).On (b)(6) 2007: (b)(6) health facility.(b)(6), md.Operative report.Preoperative and postoperative diagnosis: ventral hernia (above old incision).Anesthesia: general.Estimated blood loss: 25 cc.Procedure: ¿after satisfactory general anesthesia had been obtained, the patient's abdomen was prepped and draped in the usual sterile fashion.Upper midline incision was made and deepened down to the fascial level.Incision was extended down to the upper third of the previous incision.It was in that upper third of the previous incision where a hernia defect was encountered.Edges were freed up until we could free up the fascia.Once the fascia was freed up, placed the piece of dual-layer mesh underneath the fascia, and sutured in place using #1 prolene.We then sutured the fascial edges back over the defect and mesh using #1 deep looped pds.A drain was left in place in the subcutaneous tissue, exited through a separate stab wound.Subcutaneous tissue approximated with 3-0 vicryl, skin closed with skin staples.Drain was secured with 2-0 nylon.Abdominal dressing and a binder applied.The patient tolerated well.¿ on (b)(6) 2007: (b)(6) hospital.Implant sticker.¿gore dualmesh® biomaterial.¿ ref catalogue number: 1dlmc04.Lot batch code: 04495426.W.L.Gore & associates.Explant preoperative complaints: on (b)(6) 2008: clinic at (b)(6).(b)(6), md.History and physical.Reason for admission: has had hernias - low to mid abdomen- now with upper abdominal hernia or weakness - and major panniculus pulling on this area.History of present illness: bulge and pain in abdomen, reflux, nausea when bending over.Had panniculectomy.Now has significant ventral hernia.Pain 4/10.Physical exam: abdomen: abnormal weak upper abdomen.Assessment: ventral hernia.Plan: repair of ventral hernia.Explant procedure: ventral hernia repair.Explant date: (b)(6) 2008 (hospitalization (b)(6) 2008).On (b)(6) 2008: (b)(6) health facility.(b)(6), md.Operative report.Preoperative and postoperative diagnosis: ventral hernia, recurrent.Anesthesia: general.Estimated blood loss: 200 ml.Specimens removed: skin.Drains: none.Procedure: ¿after satisfactory general anesthesia had been obtained, the patient's abdomen was prepped and draped in the usual sterile fashion.An elliptical type of incision was made around the previous midline incision, and dissection was carried down to the fascia.The hernia was evident where mesh was still attached to the majority of the fascia but had pulled away at several places and was fairly lax.We freed this up.We were able to reduce the hernia without getting into the peritoneum.We then sutured the fascia using #1 looped pds and also #1 prolene.This made a very satisfactory repair.Subcutaneous tissue was reapproximated using 3-0 vicryl and skin was closed with skin staples.The patient appeared to tolerate the procedure well, and prognosis for recovery is good.¿ on (b)(6) 2008: (b)(6) health facility.(b)(6), md.Discharge summary.Hospital course: ¿¿.Has had multiple operations on her abdomen.She presented with a recurrent ventral hernia.We took her to surgery on the day of admission where this ventral hernia was repaired.Postoperatively, she had an abdominal binder and had a fair amount of pain.Of note, she had more muscle spasms at times than pain and so was treatable with toradol and flexeril, as well as pain medicine.She really had an uneventful recovery.Once the pain was under good control, she was able to be discharged to home.Follow up on (b)(6) 2008.Implant #4 preoperative complaints: on (b)(6) 2009: (b)(6).(b)(6), md.History and physical.Reason for admission: previous ovarian cancer while pregnant - has had hernias - low to mid abdomen- now with upper abdominal hernia or weakness - and had major panniculus pulling on this area also bothered with mammary hypertrophy and back pain - as well as fear of cancer.Physical exam: breasts: pulling pain constantly.Hypertrophic appearance; hang down to waist.Abdomen: abnormal weak left abdomen with recurrent ventral hernia.Assessment: ventral hernia, hypertrophic breasts.Plan: bilateral total mastectomies and repair of ventral hernia.On (b)(6) 2009: (b)(6) health facility.(b)(6), md.History of present illness: ¿¿ presented with mammary hypertrophy and a recurrent ventral hernia.She has had previous surgery.The weight of her breast has made it very difficult for her to do anything around the house and she had asked several months ago for consideration of bilateral mastectomy.In consultation with her husband, the patient agreed to this and wanted total mastectomies.¿ implant #4 procedure: bilateral total mastectomies, ventral hernia repair.Implant: gore® dualmesh® biomaterial [1dlmc04/06723511].Implant #4 date: (b)(6) 2009 (hospitalization (b)(6) 2009).On (b)(6) 2009: (b)(6) health facility.(b)(6), md.Operative report.Preoperative and postoperative diagnosis: bilateral mammary hyperplasia, recurrent ventral hernia.Anesthesia: general.Estimated blood loss: 350 ml.Specimens removed: breasts.Drains: jp x 3.Findings: right breast 4 lbs., left breast 3.5 lbs.Procedure: ¿after satisfactory general anesthesia was obtained, the patient's breasts were prepped and draped in the usual sterile fashion.On both sides, similar operations were conducted to remove the entire breasts, but with no attempt to dissect into the axillary area.Once completed, hemostasis was obtained by the use of electrocautery.Deeper tissues were approximated with 2-0 and 3-0 vicryl and drain was left in place on both sides and secured with a 2-0 nylon suture.The skin was then closed with skin staples.The patient was then reprepped and draped.The previous abdominal hernia scar was excised.Dissection was carried down to the hernia defect.We stayed extra peritoneal and freed up the fascia.We placed a large piece of dual layer mesh on top of the peritoneum and sewed it to the undersurface of the fascia using 0 prolene suture.The fascia was the reapproximated using #1 looped pds.The subcutaneous tissue was approximated with 2-0 and 3-0 vicryl, a11d the skin was closed with staples.Bandage and binder were applied.The patient tolerated it.¿ on (b)(6) 2009: (b)(6) health facility.Implant sticker.¿gore dualmesh® biomaterial.¿ ref catalogue number: 1dlmc04.Lot batch code: 06723511.W.L.Gore & associates.Expiration: 5/11/14.On (b)(6) 2009: (b)(6) pathology assoc., inc.(b)(6), md.Pathology.Specimen source: right breast, simple mastectomy.Left breast, simple mastectomy.Diagnosis: clinical diagnosis- breast hypertrophy both left and right.On (b)(6) 2009: (b)(6) health facility.(b)(6), md.Discharge summary.¿she was brought in the hospital on (b)(6) 2009 where bilateral total mastectomies were performed as well as a ventral hernia repair.The repair was done with mesh.Postoperatively, the patient did well.Her pain was reasonably well controlled.She had three drains in place, one for the ventral hernia and one each for the right and left breasts.All wounds seemed to heal well.She had the drains removed on the day of discharge and was discharged on (b)(6) 2009.¿ follow up on (b)(6) 2009.Relevant medical information: on (b)(6) 2018: (b)(6) medical center.(b)(6), md.Whole organ liver transplant.Cadaveric donor.[no records provided].On (b)(6) 2018: (b)(6) medical center.(b)(6), md.Laparotomy exploratory intra operative ultrasound of liver, hepatic arterial thrombectomy, revision hepatic arterial anastomosis, other indicated procedures.[no records provided].On (b)(6) 2018: (b)(6) medical center.Manuel fortes, md.Radiology.Ultrasound abdomen.Cirrhosis of the transplanted liver.2.7 cm lesion of the right hepatic dome was not seen on the (b)(6) study.Although there is no definite doppler flow, this may represent a hepatocellular carcinoma.Additionally, the left lobe of the liver is not well visualized.Further evaluation is recommended with ct liver protocol.Cholecystectomy.Splenomegaly.Large right-sided pleural effusion.On (b)(6) 2018: (b)(6) medical center.Inpatient hospital admission.On (b)(6) 2018: (b)(6), md.History and physical.¿the patient is a (b)(6)-year-old female with esld from nash.The pt has known of her liver disease for the past 3 years.She was undergoing workup for a tenth ventral incisional hernia repair when imaging demonstrated splenomegaly and findings consistent with cirrhosis.The possible hernia repair was then cancelled.¿ manifestations of liver disease have included ascites requiring paracentesis x 2.Surgical history: ¿ventral incisional hernia repairs with mesh x 9.¿ physical exam: abdomen: ¿soft.Obese.Protuberant.Mildly tender to deep palpation throughout.Transplant incision with 3 open areas without erythema.Packing and dressing changed.No rebound or guarding.Long and broad midline incision from xiphoid to pubis.No palpable masses.Bowel sounds are present.No palpable hepatosplenomegaly.¿ on (b)(6) 2018: (b)(6) medical center.(b)(6), md.Radiology.Ct abdomen and pelvis with contrast.Impression: thrombus is present within the left common iliac vein which extends into the inferior vena cava just proximal to the junction of the renal veins.Thrombus is also present in the splenic vein.Several peripheral wedge-shaped hypoenhancing hepatic lesions are most likely infarcts.Multiple splenic infarctions.Multiple portosystemic varices are present.Surgical changes of liver transplant.Mild ascites and anasarca.On (b)(6) 2018 ¿ (b)(6) 2018: (b)(6) medical center.Inpatient hospital admission.On (b)(6) 2018: (b)(6), md.History and physical.(b)(6) is a (b)(6) y.O.Female with a past medical history significant for liver transplant for nash [non-alcoholic steatohepatitis] and esld [end-stage liver disease] on (b)(6) 2018.On (b)(6) 2018: (b)(6), md.Interventional radiology.Bilateral 8 french internal/external biliary drainage catheter placement.On (b)(6) 2018: (b)(6), md.Interventional radiology.Exchange of 8 french r internal/external biliary drain for 10 french.On (b)(6) 2018: (b)(6), md.Discharge summary.Discharge physical exam: abdomen: ¿soft, obese, tender around b/l [bilateral] ptcs [percutaneous transhepatic catheters], both ptcs capped, no drainage around catheters, small opening of surgical incision healing well, exposed mesh is stable, dressing changed this am.¿ on (b)(6) 2018: (b)(6) medical center.(b)(6), md.Interventional radiology.Bilateral internal/external biliary drainage catheter exchange.On (b)(6) 2018: (b)(6) medical center.(b)(6), md.Radiology.Ct abdomen.¿impression: no acute intra-abdominal abnormality.No abscess or drainable fluid collection.Stable inferior vena cava thrombus overlying the inflow of the left renal vein and extending to the iliac bifurcation.Stable heterogenous enhancement of the transplanted liver with two percutaneous biliary drains in appropriate position.Hypodensities in the liver are stable and likely represent infarcts.Stable splenic infarct and splenomegaly.Mild ascites.Severe anasarca.¿ on (b)(6) 2018: (b)(6) medical center.(b)(6), md.Interventional radiology.Bilateral internal/external biliary drainage catheter exchange.Subcutaneous abscess drainage catheter placement utilizing ultrasound and fluoroscopic guidance.Fluid anterior to liver drained with 10 fr mpdl with 100ml cloudy yellow fluid out samples to micro.Bilateral 10 fr biliary drains changed.On (b)(6) 2018: (b)(6) medical center.(b)(6), md.Interventional radiology.Interventional radiology percutaneous drain catheter change to 12 french.On (b)(6) 2018: (b)(6) medical center.(b)(6), md.Radiology.Ct abdomen.Impression: limited non infused ct without evidence of drainable abscess.On (b)(6) 2018: (b)(6) medical center.(b)(6), md.Radiology.Ct abdomen.¿impression: no acute intra-abdominal findings.Stable mottled appearance of the transplanted liver with peripheral hypodensities likely reflecting infarcts.Stable nonocclusive ivg and splenic vein thrombus.Right abdominal wall soft tissue abscess drainage catheter without residual fluid.Biliary drainage catheters are well-positioned.Suprarenal ivc filter is stable in position.Sequela of portal hypertension.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information. it should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.".
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Event Description
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It was reported to gore that the patient underwent open ventral and incisional hernia repair on (b)(6) 2005, (b)(6) 2005, and (b)(6) 2007 whereby a gore® dualmesh® biomaterial was implanted.The complaint alleges that on (b)(6) 2005, (b)(6) 2007, (b)(6) 2008, and (b)(6) 2009, additional procedures occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: removal of previous gore mesh due to mesh migration and failure, gore mesh pulled away at several places and was fairly lax, recurrent ventral hernia defect repaired with placement of new mesh, adhesions.Additional event specific information was not provided.
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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® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.
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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.No further investigation is required at this time.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.Therefore, this event is being coded as insufficient information and no findings available and will be closed as ¿cause not established¿.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.It should be noted that the gore® dualmesh® 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.¿ medical records that indicate mesh ¿movement¿ or that the device led to a recurrence may reflect a recurrence as a function of a patient¿s poor tissue quality leading to fascial dehiscence or loss of anchorage of fixation, or may be related to the hernia type, individual patient comorbidities, and technical and procedural aspects of the repair.These factors include but are not limited to, fixation type, mesh shape/sizing used, and defect closure decisions.Additionally, a new, unrelated hernia can occur but may be referred to as a recurrent hernia.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.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.Based upon the information received, the device remains in the patient and was not available for evaluation.Review of the manufacturing 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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