PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED FREQUENT PREMATURE VENTRICULAR CONTRACTIONS FOLLOWED BY RETROSTERNAL CHEST PAIN WITH SLIGHT ST-SEGMENT CHANGES ON HER 12-LEAD ELECTROCARDIOGRAM POSTOPERATIVELY, HYPOTENSION, CONSTIPATION, DIVERTICULOSIS COLI, 1.8 CM HEPATIC LIPOMA, MILD BILIARY DILATATION LIKELY RELATED TO CHOLECYSTECTOMY AND FAT-CONTAINING MIDLINE HERNIAS, MIXED URGE AND STRESS URINARY INCONTINENCE, LOWER ABDOMINAL PAIN, NAUSEA, ACUTE CYSTITIS, AND MENOPAUSAL SYMPTOMS, PAIN, INFECTION, BLEEDING, AND DYSPAREUNIA.
N
Patient 1
(B)(4) THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ALYTE Y-MESH GRAFT MAY INCLUDE, BUT ARE NOT LIMITED TO THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS INCLUDING: ? POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. ? URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND OTHER VOIDING AND DEFECATORY DYSFUNCTIONS. THESE CONDITIONS MAY BE ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE IMPLANT. ? PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, URETHRA, RECTUM, OR ANY VISCERA, WHICH MAY OCCUR DURING THE IMPLANTATION PROCEDURE. ? IRRITATION AT THE OPERATIVE WOUND SITE WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO WOUND DEHISCENCE, INFLAMMATION AND/OR INFECTION. ? EXTRUSION THROUGH VAGINAL EPITHELIUM OR EROSION INTO SURROUNDING VISCERA AND/OR MUCOSA. ? INFLAMMATION, SENSITIZATION, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF VAGINAL WALL PROLAPSE. ? URINARY INCONTINENCE (STRESS AND URGE). (B)(4).
N
Patient 1
(B)(4). ORIGINAL REPORTING TIME FRAME (B)(4) 2014. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
N
Patient 1
(B)(4). ORIGINAL REPORTING TIME FRAME MARCH 1, 2014 TO APRIL 30, 2014. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.