Coloplast 52081Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708932553773), received between Sep 14, 2022 and Aug 15, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED: ON OR ABOUT (B)(6) 2023, PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT HER PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE, DURING WHICH HER PHYSICIAN IMPLANTED COLOPLAST ALTIS BLADDER SLING MESH AND RESTORELLE Y-MESH. PATIENT SUBSEQUENTLY SUFFERED COMPLICATIONS ASSOCIATED WITH THE PELVIC MESH PRODUCT, INCLUDING BUT NOT LIMITED TO, VAGINAL, PELVIC AND ABDOMINAL PAIN, EROSION, EXTRUSION, PROTRUSION, URINARY ISSUES (URGENCY), [INCONTINENCE] RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS, PELVIC FLOOR DYSFUNCTION, VAGINAL SCARRING, PERMANENT DISFIGUREMENT, AND DIFFICULTY WITH DAILY ACTIVITIES WHICH ULTIMATELY REQUIRED SURGICAL INTERVENTION AND REMOVAL OF MESH ON (B)(6) 2023. PATIENT HAS SUFFERED SEVERE EMOTIONAL PAIN AND INJURY AND HAS SUFFERED AND WILL SUFFER APPREHENSION OF INCREASED RISK FOR INJURIES, INFECTIONS, PAIN, MENTAL ANGUISH, DISCHARGE, AND MULTIPLE REMOVAL AND/OR CORRECTIVE SURGERIES AS A RESULT OF IMPLANTATION OF PELVIC MESH PRODUCTS.

  Patient problems: Abnormal Vaginal Discharge; Abnormal scarring; Adhesion(s); Cramp(s) /Muscle Spasm(s); Deformity/ Disfigurement; Dyspareunia; Emotional Changes; Erosion; Hematuria; Hemorrhage/Blood Loss/Bleeding; Inflammation; Intermenstrual Bleeding; Micturition Urgency; Pain; Pelvic Pain; Unspecified Infection; Urinary Incontinence; Urinary Tract Infection

  MAUDE report 22817473 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, THE LEGAL REPRESENTATIVE STATED SUSTAINED PERMANENT PAIN, PERFORATION, DISABILITY, IMPAIRMENT OF MOBILITY, IMPAIRMENT OF SEXUAL FUNCTION, IMPAIRMENT OF BOWEL AND BLADDER FUNCTION, CHRONIC INFLAMMATION, CHRONIC FOREIGN BODY REACTION, ENTRAPMENT, AGGRAVATION, IRRITATION AND/OR COMPRESSION OF HER OBTURATOR, PUDENDAL AND/OR ILIOINGUINAL NERVE WHICH IN TURN DAMAGED AND AGGRAVATED THE SURROUNDING SOFT TISSUES. AS A RESULT, THE PATIENT ALSO EXPERIENCED PARESTHESIA, DEPRESSION, AND EMOTIONAL DISTRESS. THE PATIENT EXPERIENCED EROSION, DYSPAREUNIA, NEUROMUSCULAR PAIN, PUDENDAL NEURALGIA, DISABLING PELVIC PAIN, ABDOMINAL PAIN, GROIN PAIN, RECURRENCE OF INCONTINENCE, ORATION, VAGINAL SCARRING AND HAS UNDERGONE MEDICAL TREATMENT.

  Patient problems: Bacterial Infection; Depression; Distress; Dyspareunia; Erosion; Fecal Incontinence; Foreign Body Reaction; Neuralgia; Pain; Paresthesia; Perforation; Scar Tissue; Sexual Dysfunction; Unspecified Kidney or Urinary Problem; Unspecified Tissue Injury; Urinary Incontinence

  MAUDE report 15418837 ↗