| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AJUST ADJUSTABLE SINGLE INCISION SLING | BARD SHANNON LIMITED | PAH | NA | BRD700SI | HUZA1599 | Y | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-07-31 | 0 |
Patient 1
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.
Patient 1
IT WAS REPORTED THAT THE ANCHOR WAS PUSHED AGAINST THE RAMUS (BONE) AND THE ANCHOR BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient 1
RECEIVED 1 USED AJUST MESH IMPLANT WITH THE INTRODUCER/TROCAR AND THE ORIGINAL UNIT STICKER. VISUAL INSPECTION NOTED THAT THE MESH IMPLANT HAD BEEN SECTIONED AND THE FIXED ANCHOR WAS NOT RETURNED WITH THE SAMPLE. FURTHER INSPECTION NOTED THAT THE POST OF THE ADJUSTABLE ANCHOR HAD BROKEN OFF. THE BROKEN POST WAS NOT RETURNED WITH THE SAMPLE. THE REPORTED EVENT WAS CONFIRMED AS USER-RELATED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "DESCRIPTION THE ADJUST ADJUSTABLE SINGLE-INCISION SLING SYSTEM IS A MINIMALLY INVASIVE SUBURETHRAL SLING INTENDED FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE. THE SYSTEM CONSISTS OF AN ADJUSTABLE POLYPROPYLENE MESH SLING WITH PERMANENT, SELF-FIXATING, POLYPROPYLENE ANCHORS, AN INTRODUCER, AND A FLEXIBLE STYLET FOR ADVANCING THE SLING LOCK AFTER ADJUSTMENT. THE DEVICE IS TERMINALLY STERILIZED BY ETHYLENE OXIDE. INDICATIONS FOR USE THE AJUST ADJUSTABLE SINGLE-INCISION SLING SYSTEM IS INDICATED FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE RESULTING FROM URETHRAL HYPERMOBILITY AND/OR INTRINSIC SPHINCTER DEFICIENCY. CONTRAINDICATIONS THE AJUST SLING SYSTEM IS CONTRAINDICATED FOR PATIENTS EXPERIENCING ANY OF THE FOLLOWING CONDITIONS: PREGNANCY, URINARY TRACT INFECTION, ANTICOAGULANT THERAPY, AND/OR INFECTION IN THE OPERATIVE FIELD. WARNINGS THE IMPLANT PROCEDURE AND THE INSTRUMENTATION ASSOCIATED WITH THE SURGICAL PLACEMENT OF THE AJUST SLING SYSTEM CARRY AN INHERENT RISK OF INFECTION AND BLEEDING, AS DO SIMILAR UROLOGICAL PROCEDURES. THE USE OF SURGICAL STAPLES, CLIPS, SCREWS, OR OTHER NON-SUTURE ATTACHMENT MECHANISMS NOT SUPPLIED WITH THE AJUST? SLING SYSTEM CAN DAMAGE THE IMPLANT. AFTER USE, THE PRODUCT AND ITS PACKAGING SHOULD BE TREATED AS A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS. PRECAUTIONS THE USUAL PRECAUTIONS ASSOCIATED WITH UROLOGICAL PROCEDURES SHOULD BE FOLLOWED: ? AN EXPERIENCED AND TRAINED PHYSICIAN MUST DETERMINE - BASED ON THOROUGH PREOPERATIVE ASSESSMENT - WHETHER THE PATIENT AND THE UNDERLYING CONDITION IS SUITABLE FOR THE IMPLANT PROCEDURE. ADDITIONAL CONSIDERATION SHOULD BE GIVEN TO USE OF THE IMPLANT IN PATIENTS WITH A COMPROMISED IMMUNE SYSTEM, ANY CONDITION THAT WOULD COMPROMISE HEALING, OR ANY PATIENT WITH A HISTORY OF PRIOR ABDOMINAL OR PELVIC SURGERIES. CONSIDERATION SHOULD ALSO BE GIVEN TO THE ABILITY OF THE PATIENT TO TOLERATE THE SURGICAL PROCEDURE. ? ACCEPTED SURGICAL PRACTICE AND PRECAUTIONS MUST BE FOLLOWED FOR THE MANAGEMENT OF CONTAMINATED OR INFECTED WOUND SITES, WHEN THE AJUST? SLING SYSTEM IS USED. ? POSTOPERATIVE BLEEDING MAY OCCUR IN SOME PATIENTS AND MUST BE CONTROLLED PRIOR TO PATIENT RELEASE. ? THE IMPLANT PROCEDURE REQUIRES DILIGENT ATTENTION TO ANATOMICAL STRUCTURES AND DILIGENT CARE TO AVOID INJURY OF LARGE VESSELS, NERVES, BLADDER, BOWEL, URETHRA AND ANY VISCERA DURING INTRODUCER PASSAGE. ? ANATOMICAL DISTORTION CAN RESULT FROM PELVIC ORGAN PROLAPSE. IF THE PATIENT REQUIRES CYSTOCELE REPAIR, IT SHOULD BE PERFORMED PRIOR TO THE IMPLANTATION OF THE SUB-URETHRAL SLING. ? PROPER PLACEMENT OF THE SLING IMPLANT AT THE MID-URETHRA REQUIRES THAT IT LIE FLAT WITH MINIMAL OR NO TENSION UNDER THE URETHRA. ? THE AJUST SLING SYSTEM IS INTENDED AS A SINGLE-USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THE AJUST SLING SYSTEM. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. ? PATIENTS SHOULD BE ADVISED THAT PREGNANCY FOLLOWING A SLING IMPLANT PROCEDURE MAY NEGATIVELY AFFECT THE SUCCESS OF SUCH IMPLANT PROCEDURE AND INCONTINENCE MAY RECUR. THE PATIENT IS ADVISED TO CONSULT WITH THE PHYSICIAN IN CASE OF A PLANNED PREGNANCY. ? THE SAFETY AND EFFECTIVENESS OF THE AJUST SLING SYSTEM IMPLANT PROCEDURE HAS NOT BEEN ESTABLISHED FOR THE TREATMENT OF STRESS URINARY INCONTINENCE IN MALES OR CHILDREN UNDER THE AGE OF 18. ? CYSTOSCOPY CAN BE CONSIDERED AT THE PHYSICIAN?S DISCRETION. ? CHECK THE INTEGRITY OF THE PACKAGING BEFORE USE. DO NOT USE THE IMPLANT OR INTRODUCERS IF THE PACKAGING IS OPENED OR DAMAGED. ? AS FOR ANY IMPLANTABLE MATERIAL, IT IS RECOMMENDED TO OPEN THE PACKAGE AT THE TIME OF IMPLANTATION. ? UPON OPENING THE AJUST SLING SYSTEM TRAY, THE COMPONENTS SHOULD BE CAREFULLY TRANSFERRED INTO THE STERILE FIELD. THE TRAY SHOULD NOT BE INVERTED TO REMOVE COMPONENTS. ? POST-OPERATIVELY THE PATIENT SHOULD BE ADVISED TO REFRAIN FROM HEAVY LIFTING, EXERCISE (E.G. CYCLING, JOGGING) AND/OR INTERCOURSE UNTIL THE PHYSICIAN DETERMINES IT IS SUITABLE FOR THE PATIENT TO RETURN TO NORMAL ACTIVITIES. ADVERSE EVENTS COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE AJUST SLING SYSTEM MAY INCLUD...