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Catalog Number 5950008 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Diarrhea (1811); Pain (1994); Obstruction/Occlusion (2422)
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Event Date 09/07/2016 |
Event Type
Injury
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Manufacturer Narrative
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No additional details have been provided.Multiple attempts have been made to obtain additional details of the case, however to date there has been no response.No lot number has been provided; therefore a review of the manufacturing records could not be conducted.Based on the limited information available at this time, no conclusions can be made to the degree to which the bard ventralex hernia patch contributed to the reported post-op complication.Should additional information be obtained, a supplemental mdr 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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It was reported that 3 months post implant of a bard ventralex hernia patch the patient experienced a bowel obstruction.No further details available at this time regarding patient condition and treatment.Surgeon has been asked to supply additional information.
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Manufacturer Narrative
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This is an addendum to the initial mdr to document additional information provided.As reported following implant the patient presented with the symptoms of pain, bloating and rectal bleeding, and an mri eliminated small bowel obstruction.The additional information provided states that the patient has a history of pain, bloating and rectal bleeding prior to mesh placement.Additionally, as reported the patient has had no further episodes of possible adhesive obstruction.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the additional information provided at this time, no conclusions can be made to the degree to which the bard device in question may have contributed to the reported post-op complication.Should additional information be obtained, a supplemental mdr will be submitted.
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Event Description
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It was reported that 3 months post implant of a bard ventralex hernia patch the patient experienced a bowel obstruction.No further details available at this time regarding patient condition and treatment.Surgeon has been asked to supply additional information.This is an addendum to the initial mdr as additional information has been provided by the surgeon.On (b)(6) 2016 - patient underwent umbilical hernia repair and was implanted with a bard ventralex st hernia patch.One defect presented and two additional underlying hernia were noted.The hernia patch was placed preperitoneal.The surgeon separated the peritoneal space.The hernia patch was fixated with absorbable pdo sutures.The surgeon notes that the implant presented with normal properties, no problems experienced.On (b)(6) 2016 - patient reported normal post operative pain, during follow up visit.On (b)(6) 2016 - patient presented to the er with abdominal pain, bloating and rectal bleeding.Mri eliminated small bowel obstruction as a cause.On (b)(6) 2017 - patient presented with pain, vomiting, diarrhea and distended abdomen.On (b)(6) 2017 - patient has no further episodes of possible adhesive obstruction, still reports irregular bowel movements.
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Search Alerts/Recalls
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