ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC
Received Jul 17, 2026 · Event occurred Jul 10, 2026
Report 1018233-2026-04722 · MDR key 25860465
Device
Generic name
Align® Urethral Support System Retropubic
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
BRD100R
Lot number
HUUA0182
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
65 YR · Female
- Erosion
- Unspecified Infection
- Pain
- Perforation
- Depression
- Fungal Infection
- Prolapse
- Hematuria
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Pelvic Pain
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. ALL AVAILABLE UDI INFORMATION IS BEING PROVIDED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED BLADDER INFECTION, YEAST INFECTION, PAIN, VAGINAL BLEEDING, BLADDER BLEEDING, VAGINAL PAIN, DEPRESSION, MESH EROSION, PERFORATED URETHRA AND VAGINAL WALL, SUBSEQUENT DYSTROPHIC CALCIFICATION OF PATIENT'S UNDERLYING MESH, PELVIC PAIN, HEMATURIA, VAGINAL LESION, PROLAPSED BLADDER, REQUIRED SURGICAL INTERVENTION TO REMOVE THE MESH AND TWO COURSES OF ANTIBIOTICS. PATIENT MAY ALSO REQUIRE AN ADDITIONAL SURGERY IN THE FORESEEABLE FUTURE.