Description of Event or Problem · 1
IT WAS REPORTED IN THE PT'S MEDICAL RECORDS THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED BILATERAL PELVIC PAIN, NAUSEA, MINIMAL BLEEDING, LEFT-SIDED BUTTOCK PAIN, CYSTOCELE (CORRECTED AFTER AVAULTA, RECURRENT, AND GRADE 2), "DOES NOT HAVE THE CONTROL TO STOP AND START URINATION," URGENCY, URINARY INCONTINENCE (RECURRENT, RESOLVED AFTER TOT, MILD, OCCASIONAL, AND RESOLVED), "STRING HANGING OUT OF HER VAGINA," MILD STOMACH CRAMPS, ABDOMINAL CRAMPING, ABDOMINAL PAIN (GENERALIZED, OCCASIONAL, AND "RESIDES AFTER RESTING"), OCCASIONAL PINK DISCHARGE, URINARY INTERMITTENCY, NOCTURIA, GROSS HEMATURIA, SMALL AREA OF WOUND SEPARATION WITH 1CM OF EXPOSED MESH AT THE VAGINAL INCISION SITE, SHARP PAIN THAT STARTS AT THE VAGINA AND MOVES UP TOWARD THE BLADDER, "DOES NOT ALWAYS KNOW WHEN SHE NEEDS TO URINATE," EXCISION OF MESH AND REVISION OF VAGINAL WOUND, EROSION OF VAGINAL MESH, SURGICAL SPECIMEN FRAGMENTS OF REACTIVE STOMA AND SQUAMOUS EPITHELIUM WITH ACUTE AND CHRONIC INFLAMMATION, RECURRENT URINARY TRACT INFECTION, PAINFUL URINATION, PAIN AFTER VOIDING, FREQUENCY, INCOMPLETE EMPTYING, GRADE 2 RECTOCELE, MESH PALPABLE JUST BENEATH THE SURFACE BUT NO SIGNIFICANT EROSION, PAIN IN THE LOWER LEFT ABDOMINAL AREA, AND "FEELS MESH COMING OUT" AFTER SHE UNDERWENT CYSTOCELE REPAIR WITH INLAY OF MESH, VAGINAL VAULT SUSPENSION, TRANSOBTURATOR TAPE MIDURETHRAL SLING AND CYSTOSCOPY. IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, AND PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, AND WILL LIKELY UNDERGO CORRECTIVE SURGERY OR SURGERIES. ASSOCIATED MDR: 1018233-2013-01074.