ProSup TECGK06Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521177604), received between Aug 5, 2024 and Jun 23, 2025 — classified as 3 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A PROMONTOFIXATION PROCEDURE IN 2015 USING A MESH AND TACKER, FOLLOWING THIS, A SUBTOTAL COLECTOMY WAS PERFORMED IN 2016 DUE TO COLONIC DECOMPENSATION, AND A RECURRENCE OF PROLAPSE WAS NOTED IN 2017, ASSOCIATED WITH PELVIC FLOOR COLLAPSE, VAGINAL GAP AND ANAL SPHINCTER HYPERTONIA. ADDITIONAL SURGERY (RICHTER¿S SACRO-SPINOFIXATION AND POSTERIOR PERINEORRHAPHY) WAS CONDUCTED IN 2017 WITH SEEMINGLY UNEVENTFUL RECOVERY. HOWEVER, THE PATIENT'S CONDITION HAS SINCE WORSENED, LEADING TO CHRONIC PAIN, FATIGUE, EARLY DISABILITY RETIREMENT, FINANCIAL HARDSHIP, AND SEVERELY DIMINISHED QUALITY OF LIFE. IN 2018, THE PATIENT BEGAN EXPERIENCING SEVERE BILATERAL NEUROPATHIC LEG PAIN, NOW REQUIRING SIGNIFICANT REST TO MANAGE. DESPITE REGULAR ELECTROMYOGRAPHY (EMG) FOLLOW-UPS AND THE NEUROPATHY BEING CLASSIFIED AS IDIOPATHIC. NO CORRECTIVE ACTION OR INTERVENTION FROM THE HEALTHCARE FACILITY HAS BEEN REPORTED TO DATE.

  Patient problems: Fatigue; Laceration(s); Pain; Prolapse

  MAUDE report 22312350 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE WERE URINARY PROBLEMS POSTOPERATIVELY: PAIN DURING URINATION, SIGNIFICANT DIFFICULTY URINATING, AND SLIGHT INCONTINENCE DURING EXERCISE. THE PATIENT IMMEDIATELY FELT VERY STRONG ABDOMINAL PAIN, MAINLY IN THE SCARS, WHICH CORRESPONDED TO THE ATTACHMENT POINTS, AND PAIN AND DISCOMFORT IN THE URETHRA AND VAGINA. THE PATIENT ALSO NOTED AN INTRAVAGINAL FOREIGN BODY SENSATION AND WAS STILL EXPERIENCING DYSURIA. QUICKLY, LUMBAR, SACROILIAC, AND GLUTEAL PAIN WAS ALSO FELT, A BIT LIKE SCIATICA. THESE PAINS BECAME MORE PRONOUNCED UNTIL THEY BECAME UNBEARABLE, AND INSOMNIA WITH DIFFICULTY WALKING. THE PATIENT WENT TO THE HOSPITAL AND HAD A LOCO-DOLENTI INFILTRATION WITH XYLOCAINE 1% 10 ML. POST-INFILTRATION EXAMINATION CONFIRMED A POSITIVE BLOCK. THIS INFILTRATION WAS CATASTROPHIC; THE PATIENT COULD NO LONGER WALK, COMPLETELY BLOCKED IN THE PELVIS, AND THIS AMPLIFIED THE PAIN. CURRENTLY, THE PATIENT STILL HAS URINARY PROBLEMS: STINGING SENSATIONS IN THE URETHRA, BURNING, DYSURIA, DIFFICULTY URINATING, AND THE SENSATION OF AN INTRAVAGINAL FOREIGN BODY WITH PAIN THAT HAS AN IMPACT ON SEXUAL INTERCOURSE. ABDOMINAL PAIN IS ALSO STILL PRESENT AND MUCH MORE INTENSE,

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Dysuria; Pain; Sexual Dysfunction

  MAUDE report 22216441 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, EIGHT YEARS FOLLOWING A PROCEDURE WHERE VAGINAL WOUNDS OCCURRED INTRA-OPERATIVELY AND A POLYESTER PROSTHESIS HAS BEEN PUT IN PLACE, THE PATIENT HAD PELVIC ABSCESS ON VAGINAL PROSTHETIC EXPOSURE. THE PATIENT REQUIRED REOPERATION FOR COMPLETE PROSTHETICS AND TACKS EXPLANTATION. THE PATIENT WAS GIVEN ANTIBIOTIC THERAPY.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 19913343 ↗