There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient.A sample mesh has been provided to the patient's allergist for reactivity testing.As reported, at this time the reactivity testing has not been completed.A review of the manufacturing records was performed and found that the lot was manufactured to specification.If/when the results of the reactivity testing have been provided, a supplemental emdr will be submitted to document the results.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.Remains implanted.
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The following was reported to davol by the patient's allergist: as reported on (b)(6) 2015 the patient underwent left inguinal hernia repair and was implanted with a bard/davol flat mesh.Soon after the implant procedure, the patient experienced pain and a rash at the incision site.As reported the rash is chronic and covered most of his body and consists of blisters and "patchy lesions." the patient has been taking steroids consistently to control the rash; however, this has not provided complete resolution of the rash.A sample mesh was requested for reactivity testing.
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