BARD / DAVOL INC., SUB. C.R. BARD, INC MARLEX MESH PERFIX PLUG; MESH, SURGICAL, POLYMERIC
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Lot Number HUEW1648 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Unspecified Infection (1930); Pain (1994)
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Event Date 04/02/2021 |
Event Type
Injury
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Event Description
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We use a hernia mesh "perfix plug large" for our hernia cases.Dr (b)(6) has noted that since (b)(6) this year he has had 3 cases where patient's complained that the area hurt.With the first 2 cases he treated them with antibiotics and they got better.His last patient occurred in (b)(6).Dr (b)(6) removed the mesh and sent it for culture.The mesh came back (b)(6).All of these were open hernias and there was no way the mesh could have touched skin when it was inserted into the body.Therefore his conclusion is the mesh is contaminated.Dr wills stated he tried to call bard, but did not get any where.This is the 3rd issue.Is therapy still on-going? no.
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