| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AJUST? ADJUSTABLE SINGLE-INCISION SLING | PAH | BARD SHANNON LIMITED | PAH | BRD705SI | HUUI1495 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-03-31 | 0 | 1. R |
Patient 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED STRESS URINARY INCONTINENCE, DYSPAREUNIA, STRESS URINARY INCONTINENCE, DYSPAREUNIA, SOME DIMPLING IN THE VAGINA DISTAL TO THE LOCATION OF THE MESH, AND MESH EROSION, AND VAGINAL PAIN FROM EXPOSED MESH NECESSITATING PERIURETHRAL INJECTION OF MACROPLASTIQUE AND Y-V PLASTY OF VAGINA, AND REMOVAL OF MESH FROM THE VAGINA AND INJECTION OF PERIURETHRAL BULKING AGENT FOLLOWING IMPLANTATION.
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. (B)(4).
Patient 1
(B)(4).
Patient 1
(B)(4).
Patient 1
(B)(4). ORIGINAL REPORTING TIME FRAME (B)(6) 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.
Patient 1
(B)(4). ORIGINAL REPORTING TIME FRAME JANUARY 1, 2014 TO FEBRUARY 28, 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.
Patient 1
(B)(4). ORIGINAL REPORTING TIME FRAME JANUARY 1, 2014 TO FEBRUARY 28, 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.
Patient 1
(B)(4). ORIGINAL REPORTING TIME FRAME JANUARY 1, 2014 TO FEBRUARY 28, 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.
Patient 1
(B)(4). 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