|
The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.Per additional information received the patient has experienced pain, erosion, extrusion, unspecified urinary problems, unspecified bowel problems, recurrence, bleeding, dyspareunia (pain during intercourse), emotional/psychological injury, upper respiratory illness exacerbated by exertion/coughing, productive cough, acute bronchitis, rales/crackles bilateral upper lobes, severe pain in left hand/wrist injured during fall, limited range of motion of left wrist/hand secondary to pain, ecchymoses (bruising), swelling in left hand, strain left wrist/hand, soft tissue swelling seen on x-rays of left wrist, synovial fluid aspirated from left knee, fatigue, hepatitis c virus (infection), elevated white blood cell count, elevated serum glucose, elevated liver enzymes, nausea, vomiting, severe left-sided migraine headache exacerbated by light/noise (headache), palpitations, chronic back pain, diarrhea, blurred vision, photophobia, sensitivity to light, anxiety, weakness, ultrasound-guided liver biopsy, melena, irregular heart rate, sore throat, frequency, depression, grade iv hepatic fibrosis (fibrosis), moderate chronic hepatic inflammation (inflammation), discomfort, tenderness at liver biopsy site, chronic obstructive pulmonary disease, shortness of breath, reports gurgling from lungs, chest pain/pressure, abdominal pain, diminished breath sounds, sinus tachycardia, abnormal electrocardiogram (inferior infarct, probable lateral infarct/old, multiple ventricular premature complexes), right rib pain, pneumonia, underweight (weight fluctuations), scarring in lungs (scarring), nondisplaced right seventh rib fracture, partially healed right sixth rib fracture, fever, productive cough, difficulty breathing (respiratory distress), bronchospasm, calf/leg pain, hyperventilation, reflux esophagitis, sharp midsternal pain, confusion, heartburn, panic attacks, epigastric pain, chronic hypoxic respiratory failure (respiratory failure), insomnia (sleep disturbances), memory issues, emphysema, urinary tract infections, kidney stones, anemia, dysphagia, bilateral knee pain (joint pain), left hip pain (joint pain), generalized weakness, vaginal/pelvic pain, worsening incontinence, multiple bruises and skin tears in nasal mucosa (tearing), bruising and skin tears to both arms (bruises, skin tears), dysuria, frequency, urgency, diffuse abdominal pain, burning upon urination (burning sensation), bladder swelling (swelling), mucous retention cysts left maxillary antrum (cysts), transient ischemic attacks (tia), flashes of light, confusion, osteopenia, extensive right sphenoid sinus mucosal thickening/sphenoid sinus disease hematuria, low platelet count, and required additional non-surgical intervention.Per additional information received, the patient has experienced burning in vagina (burning sensation), chronic pain, bladder pain, sensation of bladder swelling, dyspareunia, bleeding with sex (blood loss), going to bathroom all of the time (urinary frequency), bladder does not empty all the way (urinary retention), recurrent bladder infections, pain with urination (dysuria), stress/urge urinary incontinence, urethral stenosis, bowel obstruction, crohns disease, irritable bowel syndrome, ulcerative colitis, diverticulitis, constipation, lower abdominal pain, anxiety, thickening of the colon, nausea, vomiting, and required additional surgical and non surgical interventions.Per additional information received via medical records on august 29, 2018, the patient has experienced vaginal pain, pelvic pain, dysuria, frequency, urgency burning, upper abdominal pain, mild constipation, nausea, vomiting, lower abdominal pain, stress urinary incontinence, urge urinary incontinence, questionable stool in her vagina, and urethral stenosis.On (b)(6) 2015, (b)(6)i, md noted a possible enterovaginal or colovaginal fistula that could be related to either crohns disease or prior bladder sling procedure; it is unknown if an enterovaginal or colovaginal fistula was definitively diagnosed.She required a surgical intervention consisting of cystoscopy with urethral dilation on (b)(6) 2015.Per the pfs, the patient alleged she also experienced a bowel obstruction, ulcerative colitis, diverticulitis, dyspareunia, hypotension, pelvic tumors/fibroids, recurrent bladder infections, and urinary retention.Per additional information received via medical records on october 4, 2018, the patient has experienced abdominal pain, constipation, headache, nausea, vomiting, fistula, anxiety, stress/urge urinary incontinence, urethral stenosis, foreign body sensation, foreign body in patient, vaginal discharge, infection, vaginitis, discharge, urgency, leakage, nocturia, urinary tract infection, stool in vagina, bloody diarrhea, blood loss, hemorrhoids, additional surgical and nonsurgical interventions.Per additional information received, the patient has experienced mesh erosion, tissue erosion, exposed and protruding mesh, pain, bleeding, infection and dyspareunia.
|
|
Per additional information received on 15nov2021, the patient has experienced swollen bladder, weakness, irritable bowel syndrome, gastroesophageal reflux, kidney stones, rheumatoid arthritis, light flashing, episode of confusion, osteoporosis, hepatocellular disease, elevated heart rate, shortness of breath, gastroenteritis, mild dehydration, high dose steroid dependence, chronic immunosuppression, polycythemia, left knee osteoarthritis, gastritis, dysphagia, pain during sexual intercourse, bleeding, bladder problems, inability to empty the bladder, bowel obstruction, brain and lung cancer, ulcerative colitis, crohn¿s disease, diabetes, diverticulitis, hypotension, pelvic tumors, recurrent bladder infections, pain while urination, mixed urinary incontinence, celiac artery occlusive disease and required additional surgical and non-surgical interventions.
|
