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U.S. Department of Health and Human Services

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BRAND NAMEBARD MARLEX MESH
MANUFACTURER
BARD VASCULAR SYSTEM DIV. C.R. BARD, INC.
129 CONCORD RD
BALLERICA MA 01821
ACCESS NUMBERM522163
PRODUCT CODEFTM
PANELGENERAL AND PLASTIC SURGERY
REPORT TYPESERIOUS INJURY
DATE FDA RECEIVED06/07/1994
DEVICE CATALOGUE NUMBER011267
EVENT DESCRIPTION TYPEPRELIMINARY
EVENT DESCRIPTION
DEVICE WAS IMPLANTED 12/17/93. AFTER TWO OCCURRENCES OF INFECTIONS, PT WAS RE-ADMITTED AND HAD A "MASSIVE" INFECTION AT THE SURGICAL SITE.
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