Exair 50100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05708932459457), received between Sep 23, 2021 and Oct 22, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: THE PATIENT PRESENTED WITH A RELAPSE OF HER ANTERIOR PROLAPSE AND UNDERWENT ANTERIOR COLPORRHAPHY WITH EXAIR IN (B)(6) 2011. THE PATIENT PRESENTED WITH PELVIC PAIN AND DYSPAREUNIA. INFILTRATIONS AND PHYSIOTHERAPY WERE TRIED WITHOUT SUCCESS. THE PATIENT UNDERWENT COMPLETE REMOVAL OF THE MESH IN (B)(6) 2021 AND ANTERIOR AND POSTERIOR RECONSTRUCTION WITH COLPO-SACROPEXY IN (B)(6) 2022. FOLLOWING THESE SURGERIES, THERE IS A SIGNIFICANT RESOLUTION OF PAINFUL SYMPTOMS.

  Patient problems: Dyspareunia; Pelvic Pain

  MAUDE report 20507267 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED ANTERIOR VAGINAL WALL 5 MM MESH EROSION. EXCISION OF ERODED MESH VIA GENERAL ANESTHESIA WAS PERFORMED AND PATHOLOGY REPORT CONFIRMED MESH AND VAGINAL TYPE MUCOSA.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 20416775 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, LEGAL REPRESENTATIVE STATED THE PATIENT WITH THIS DEVICE EXPERIENCED DEVICE EROSION 1 CM IN THE APEX OF THE VAGINA. PATIENT HAD EXPLANTATION OF THE DEVICE VIA GENERAL ANESTHESIA. THE PATHOLOGY REPORT CONFIRMED A SECTION OF DEVICE MEASURING 1 X 0.5 X 0.2 CM AND VAGINAL TYPE MUCOSA.

  Patient problems: Erosion

  MAUDE report 16490373 ↗
• InjuryJun 22, 2022Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE EXPERIENCED ABNORMAL VAGINAL DISCHARGE AND BLEEDING, EROSION OF THE DEVICE INTO HER VAGINAL CUFF, RECURRENT URINARY INCONTINENCE, ABDOMINAL AND VAGINAL PAIN, RECURRENT URINARY TRACT INFECTIONS, FATIGUE, VAGINAL ODOR, FOREIGN BODY REACTION, AND OTHER INJURIES.

  Patient problems: Abdominal Pain; Abnormal Vaginal Discharge; Bacterial Infection; Constipation; Dysuria; Emotional Changes; Erythema; Fatigue; Foreign Body Reaction; Genital Bleeding; Itching Sensation; Nausea; Pain; Rectovaginal Fistula; Scar Tissue; Sepsis; Skin Erosion; Urinary Frequency / Polyuria; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 14780853 ↗
• InjuryOct 6, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT EXPERIENCED URINARY URGENCY, URGE INCONTINENCE, SUI, URINARY LEAKAGE, CONSTANT DRAINAGE SINCE SURGERY, YELLOW DISCHARGE, DYSPAREUNIA, URETHRAL HYPERMOBILITY WITH STRAINING, GRADE 2 CYSTOCELE, RECURRENT UTS AND OVERACTIVE BLADDER. PATIENT HAS BEEN PRESCRIBED ORAL AND TOPICAL MEDICATIONS TO HELP WITH SYMPTOMS.

  Patient problems: Bacterial Infection; Micturition Urgency

  MAUDE report 12585747 ↗
• InjurySep 23, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE PATIENT WITH THIS DEVICE HAD EXPERIENCED URINARY INFECTION, FREQUENT MODERATE AND ACUTE PUBLIC PAIN. POLYURIA, BURNING ON URINATION AND NAUSEA. ABDOMEN SENSITIVE TO PALPATION. C/O PERSISTENT RECTAL PROLAPSE, GROIN, PELVIC AND COCCYX PAIN. DIFFICULTY WITH URINATION, DECREASE IN MUSCULAR MASS. CT ABDOMEN AND PELVIS PERFORMED FOR PELVIC PAIN POSSIBLY ASSOCIATED WITH THE VAGINAL MESH.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 12520030 ↗