| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ALYTE Y-MESH GRAFT | OTO | BARD SHANNON LIMITED | OTO | NA | Y100 | HUVK0694 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-11-19 | 0 | 1. R |
Patient 1
IT WAS REPORTED BY THE PATIENT'S ATTORNEY, THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED SEVERE PAIN IN HER ABDOMEN, INFECTIONS, VAGINAL ABSCESSES, MESH EROSION, INJURY, AND HAS UNDERGONE FURTHER SURGICAL PROCEDURES.
Patient 1
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). EXEMPTION (B)(4). THE TOTAL NUMBER OF EVENTS FOR PRODUCT CLASSIFICATION CODE OTO IS (B)(4). THIS MDR REFLECTS THAT EVENT REPORTED. (B)(4).