inforMED
MalfunctionPAJ

ADVANTAGE FIT TRANSVAGINAL MID-URETHRAL SLING

Received Jun 24, 2019 · Event occurred May 21, 2019

Report 8727137 · MDR key 8727137

Device

Generic name

Mesh, Surgical, Urogynecologic

Lot number

23182541

Product problems

  • Patient-Device Incompatibility

Patient

16790 DA

  • Abdominal Pain
  • Itching Sensation
  • Abdominal Pain
  • Itching Sensation

Narrative

Description of Event or Problem

PATIENT UNDERWENT A URETHROPEXY USING VAGINAL TAPE REPAIR AND CYSTOCELE WITH BIOLOGIC GRAFT CYSTOSCOPY. PATIENT DISCHARGED TO HOME THE SAME SURGERY DAY. WITHIN 30 DAYS, THE PATIENT BEGAN TO EXPERIENCE INCREASING LOWER ABDOMINAL PAIN AND TREATED WITH ANTIBIOTICS FOR A UTI. THE PATIENT THEN BEGAN TO EXPERIENCE ITCHING HANDS/VAGINAL ITCHING, AND QUESTIONED IF POSSIBLY ALLERGIC TO THE VAGINAL SLING. THE MEDICATIONS WERE STOPPED AND PATIENT PLACED ON BENADRYL TO SEE IF ITCHING IMPROVED. ITCHING CONTINUED AND PATIENT PLACED ON PREDNISONE; ITCHING PERSISTED AND PATIENT PLACED ON ATARAX. THE PATIENT QUESTIONED AGAIN IF SHE WAS EXPERIENCING AN ALLERGIC REACTION TO THE SLING. A MEDROL DOSEPAK WAS RESTARTED ALONG WITH VISTARIL- WITH NO RELIEF. THE PATIENT WAS THEN SEEN BY AN ALLERGIST AND DISCUSSED POSSIBILITY OF REMOVING SLING. APPROXIMATELY FIFTY-ONE DAYS AFTER PLACEMENT OF THE SLING, THE SLING WAS SURGICALLY REMOVED. SINCE THE REMOVAL OF THE SLING THE PATIENT HAS EXPERIENCED NO FURTHER ITCHING.