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Catalog Number 5955790 |
Device Problems
Material Separation (1562); Defective Device (2588); Detachment of Device or Device Component (2907)
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Patient Problems
Unspecified Infection (1930); Sepsis (2067); Disability (2371)
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Event Date 01/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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To date no medical records have been provided for review.It is unclear what is meant by "the mesh separated" as stated in the legal claim.Based on the information obtained from the legal claim, at this time no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the alleged patient outcome.Should additional information be obtained, a supplemental mdr will be submitted.Regarding infection the warning section of the instructions for use (ifu) states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection, however, may require removal of the prosthesis." additionally, recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section of the ifu as a possible complication.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.
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Event Description
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The following was alleged by the patient's attorney: on (b)(6) 2015 - the patient underwent the repair of a right ventral incisional hernia.During this procedure a bard ventralight st w/ echo ps was used to complete the repair.On (b)(6) 2015 - the patient presented to the emergency department with complaints of fever and chills.As reported, the patient was found to be febrile and tachycardic and diagnosed with an infection at the incision site, which required wound vac placement.It is alleged that at or about this time, the mesh separated, detached and became exposed, requiring physicians to trim portions of the mesh protruding from the skin on several occasions.On (b)(6) 2015 - (b)(6) 2016 - a visible protrusion at the lateral aspect of the right subcostal scar developed and steadily worsened, eventually becoming 6 to 7cm in diameter and during this time the patient repeatedly sought medical treatment for the worsening protrusion, pain, discomfort and secondary symptoms associated with the mesh.The patient was diagnosed with a hernia recurrence and informed that the mesh had to be removed.On (b)(6) 2017 - the patient underwent a surgical separation (explant) of the mesh.Additional allegations in the legal claim also include, sepsis without evidence of severe sepsis, gastrointestinal and urinary dysfunction, severe scarring and disfigurement, inability to enjoy various pleasures of life and participate in various activities that were previously enjoyed and loss and impairment of general health, strength and vitality.
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Manufacturer Narrative
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Addendum to the previous report.This supplemental emdr is being sent to provide additional patient identifiers and medical information based on the patient's medical records.With the current information the conclusion for this file remains inconclusive.
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Event Description
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As previously reported in 10/2017: on (b)(6) 2015: the patient underwent the repair of a right ventral incisional hernia.During this procedure a bard ventralight st w/ echo ps was used to complete the repair.On (b)(6) 2015: the patient presented to the emergency department with complaints of fever and chills.As reported, the patient was found to be febrile and tachycardic and diagnosed with an infection at the incision site, which required wound vac placement.It is alleged that at or about this time, the mesh separated, detached and became exposed, requiring physicians to trim portions of the mesh protruding from the skin on several occasions.05/09/2015 - 10/11/2016: a visible protrusion at the lateral aspect of the right subcostal scar developed and steadily worsened, eventually becoming 6 to 7cm in diameter and during this time the patient repeatedly sought medical treatment for the worsening protrusion, pain, discomfort and secondary symptoms associated with the mesh.The patient was diagnosed with a hernia recurrence and informed that the mesh had to be removed.On (b)(6) 2017: the patient underwent a surgical separation (explant) of the mesh.Additional allegations in the legal claim also include, sepsis without evidence of severe sepsis, gastrointestinal and urinary dysfunction, severe scarring and disfigurement, inability to enjoy various pleasures of life and participate in various activities that were previously enjoyed and loss and impairment of general health, strength and vitality.Addendum per medical records: in (b)(6) 2015 the patient was admitted to the hospital with purulent drainage from abd wound.Patient¿s wound became much more cellulitic and indurated with increased purulence.The patient¿s wound was opened at bedside with mesh exposure.The wound was packed with gauze followed by a wound vac.He was diagnosed with sepsis and treated with iv antibiotics.About 2 years later on (b)(6) 2017 the patient was diagnosed with a ventral hernia and underwent repair of ventral hernia with implant of a non bard/davol ¿gore-bio-a mesh¿ 9 x 15 cm, excision of scar and layered closure of 23 cm, debridement of fascia including mesh (ventralight st).Post operatively on (b)(6) 2017 the patient had follow up office visit with wound dehiscence noted.
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Search Alerts/Recalls
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