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Catalog Number UNKAA089 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
Itching Sensation (1943); Rash (2033); Reaction (2414); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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Based on the information available at this time, no conclusions can be made.Allergic reaction is listed in the adverse reaction section of the ifu as a possible complication.No lot number has been provided; therefore no dhr review and related manufacturing process reviews could be performed.To date the reactivity testing has not been completed.If/when the reactivity testing is completed, and the results are 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.Remains implanted.
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Event Description
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It was reported that on (b)(6) 2015 the patient was implanted with a bard ventrio st hernia patch.As reported the patient has had a rash since implant.It is reported that the site was oozing, but was not itchy until it "exploded" (contact could not explain what was meant by exploded), then it became itchy.The patient has been treating the site with iodine (otc) to dry it out.He does not have any known allergies, the doctors office is going to test for a reaction to iodine and to medication he is taking.A sample mesh has been requested and provided to the patient's allergist for reactivity testing of the mesh as well.As reported the patient has an appointment scheduled, but the doctor's office reports it is unknown if the testing will performed during that visit.
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Manufacturer Narrative
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This is an addendum to the initial mdr to report that reactivity testing with the provided sample mesh has been completed.The results of the test were negative for any adverse reaction.Additionally, the patient's doctor performed a biopsy at the affected site and those results were negative as well.Based on this additional information it does not appear that the patient was having a reaction to the bard mesh.Should additional information regarding the patient condition be provided, a supplemental mdr will be submitted.
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Search Alerts/Recalls
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