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Catalog Number UNKAA016 |
Device Problems
Defective Device (2588); Extrusion (2934); Insufficient Information (3190)
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Patient Problems
Adhesion(s) (1695); Fistula (1862); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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Currently, it is unknown whether the device may have caused or contributed to the reported event.Medical records have not been provided to date.Without a lot number a review of the manufacturing records could not be conducted.It was alleged the patient experienced adhesions, fistula, pain, erosions and extrusion of mesh.Adhesions, fistula and extrusion are listed as known possible adverse reactions in the instructions-for-use.With the currently available information, no conclusion can be drawn.If additional event and/or evaluation information is obtained, a follow up 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 to manufacturer.
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Event Description
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The following was reported to davol by the patient's attorney: (b)(6) 2005 - patient underwent multiple supraumbilical and periumbilical incisional hernia repairs.During the procedure, the surgeon implanted a kugel composix mesh into the patient's abdomen intending to repair various hernias.On (b)(6) 2014 - patient experienced some pain in his abdomen on or around the location of his previous hernia repairs, and when he looked down he realized that he was bleeding and that the implanted mesh product was protruding through his skin.Patient immediately went to the hospital for evaluation where the wound was patched and the patient was subsequently scheduled for an exploratory laparotomy and excision of the existing mesh product.On (b)(6) 2014 - patient presented to the hospital, for the exploratory laparotomy and excision of the existing mesh product.During the surgery and exploration the surgeon discovered that there were approximately two feet of adhesions of the small bowel to the product mesh along with an enterocutaneous fistula.The surgeon noted that there were three areas where there had been erosion into the bowel by the product.The attorney alleges the patient experienced pain, adhesions, fistula, extrusion and erosion.
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Search Alerts/Recalls
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