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BRAND NAMEMARLEX MESH
MANUFACTURER
DAVOL, INC.
P.O. BOX 8500
CRANSTON RI 02920
ACCESS NUMBERM753951
PRODUCT CODEFTM
PANELGENERAL AND PLASTIC SURGERY
REPORT TYPESERIOUS INJURY
DATE FDA RECEIVED04/15/1996
DEVICE CATALOGUE NUMBERUN
EVENT DESCRIPTION TYPEFINAL
EVENT DESCRIPTION
APPROX TWO YEARS AGO A SURGEON REPAIRED A LEFT INGUINAL HERNIA LAPAROSCOPICALLY USING SURGICAL MESH. THE PT DID FINE FOR TWO YEARS THEN PRESENTED TO HIS UROLOGIST WITH GROSS HEMATURIA. SUBSEQUENT CYSTOSCOPY DEMONSTRATED BLADDER STONES AND AN ERODED/ULCERATED AREA OF THE BLADDER. AT THE BASE OF THE ULCER WAS THE SURGICAL MESH WHICH HAD APPARENTLY ERODED THROUGH THE BLADDER CAUSING THE BLEEDING AND PROBABLY SERVING AS A FOREIGN BODY NIDUS FOR THE BLADDER STONE.
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