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Catalog Number 0117070 |
Device Problem
Material Deformation (2976)
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Patient Problems
Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994)
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Event Date 12/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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As reported, the patient alleged chronic pain, meshoma, internal bleeding and cutaneous femoral nerve post implant of perfix light plug.As reported no additional information will be forthcoming.Based on the information provided, no conclusion can be made as to the degree to which the device, may be causing or contributing the patients reported postoperative symptoms.The instructions-for-use supplied with the device lists pain as a possible complication.This is the only reported complaint to date for the reported lot number.This emdr represents the bard/davol perfix plug light (device #1).An additional emdr was submitted to represent the bard/davol perfix plug light (device #2).Should additional information, a supplemental mdr will be submitted.Not returned.
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Event Description
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The following was reported via tga report ((b)(6) fda): as reported the complaint cites the use of two perfix light plugs.The tga report states, "i went to see a surgeon regarding right hand side pain, i did a dye ct test and a small inguinal sac was found on the left.I went in to have the hernia repair done, i had 2 plugs put in and a large mesh on a genital femoral hernia that was not detected on dye ct scan.Patient outcome/consequences: cutaneous femoral nerve, meshoma, internal bleeding [redacted] was surprised i lasted as long as i did.After removing the mesh to the genital femoral area there was no hernia found.I have ongoing chronic pain which seen a neurostimulator was placed in my back.I have lost my dysfunctional in my sex life.Recently i have started coming down to with crps, i am due to have a ketamine infusion to lessen the pain.The mesh that was put in place did not need to be there, also this mesh has caused me chronic pain and now i am suffering crps.".
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Search Alerts/Recalls
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