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Catalog Number UNKAA078 |
Device Problems
Material Deformation (2976); Migration (4003)
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Patient Problems
Unspecified Infection (1930); Hernia (2240); Impaired Healing (2378)
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Event Date 05/22/2018 |
Event Type
Injury
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Manufacturer Narrative
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Based on the information provided we are unable to determine to what extent, if any the ventralight st mesh may have caused or contributed to the events as alleged.The maude event report did not provide contact information for the complainant, therefore at this time we are unable to request additional information.Infection and recurrence are known inherent risks of hernia repair surgery.Regarding infection and recurrence the instructions-for-use states."if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." and "to prevent recurrences when repairing hernias, the prosthesis should be large enough to extend beyond the margins of the defect at least 3 to 5 cm." a lot number was not provided, without this information a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.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 reported via maude event report (mw5078177): "abdominal mass surgery required an emergency mesh implant of a bard ventralight st.Within a week i developed a serious infection and was hospitalized.My wound did not close within 5 months.Even with assistance from a wound vac.I started having bowel problems, cysts, fevers, infections, wound drainage, teeth deterioration, pain, inflammation, bloating, swelling, heat generating from my stomach where my mesh was.I developed a hernia, and found that my mesh had dislocated and was in a ball.I also developed streptococcus b.On (b)(6) 2018, i had my mesh removed and my hernia repaired.Since the mesh was removed, i have not had an infection, my wound closed fully within 3 weeks.The pathology reported rendered on the removed, mesh came back infected and dislocated.".
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Search Alerts/Recalls
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