AdVance 720088-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00878953005300), received between Jan 5, 2018 and Aug 22, 2019 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2019Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO PASS THE NEEDLE UNTO THE SLING IT BROKE AWAY. THE DEVICE WAS UNABLE TO BE USED AND A NEW SLING DEVICE HAD TO OPENED FOR BACKUP. THERE WERE NO PATIENT ADVERSE EFFECTS IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8921287 ↗
• MalfunctionJul 31, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, ON THE RIGHT SIDE, THE MALE SLING RIP IN HALF WERE THE PHYSICIAN COULD HAVE CUT. THE SLING REMAINS IMPLANTED. NO INFORMATION ABOUT THE PATIENT OUTCOME IS AVAILABLE AT THE MOMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8847784 ↗
• InjuryOct 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE ADVANCE SLING IMPLANT PROCEDURE THE DEVICE WAS TENSIONING THE CASE. A SMALL PORTION OF ONE OF THE SLING ARMS TORE WHEN THE PHYSICIAN WAS PULLING THE SLING TO RELOCATE THE URETHRA. THE DEVICE WAS SUCCESSFULLY IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7960952 ↗
• InjuryJun 18, 2018Malposition of Device; Malposition of Device

  FOLLOWING THE IMPLANT OF AN ADVANCE MALE SLING THE PATIENT'S INCONTINENCE INITIALLY IMPROVED. THE PATIENT THEN EXPERIENCED RECURRING INCONTINENCE AND WAS IMPLANTED WITH ANOTHER CONTINENCE DEVICE. THE PHYSICIAN IMPLANTING THE NEW URINARY SPHINCTER DEVICE "BELIEVED THE SLING WAS NOT PLACED APPROPRIATELY ON THE URETHRA BASED ON THE ENTRY/EXIT OF THE NEEDLES THROUGH THE OBTURATOR FORAMEN". NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION WITH THIS EVENT.

  Patient problems: Incontinence

  MAUDE report 7608989 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ADVANCE SLING, HE EXPERIENCED WORSENED LEVELS OF INCONTINENCE. HE WAS IMPLANTED WITH ANOTHER CONTINENCE DEVICE ON (B)(6) 2018. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION WITH THIS EVENT.

  Patient problems: Incontinence

  MAUDE report 7455618 ↗
• InjuryJan 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE IMPLANTATION OF AN ADVANCE SLING, THE PATIENT EXPERIENCED "EROSION OF THE MESH" AND THE INCONTINENCE BECAME WORSE. THE PATIENT WAS IMPLANTED WITH ANOTHER INCONTINENCE DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION WITH THIS EVENT.

  Patient problems: Erosion; Incontinence

  MAUDE report 7198512 ↗
• InjuryJan 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ADVANCE SLING, THE "SLING ERODED THROUGH URETHRA". THE SLING MESH WAS REMOVED AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION WITH THIS EVENT.

  Patient problems: Erosion

  MAUDE report 7167035 ↗