ProSup TECLGK01Recalls & reported problems
Covidien LP · Pelvic Floor Repair Mesh,Polyester,Height: 4.5 cm;2.5 cm;3 cm · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521177611), received between Mar 1, 2022 and Mar 28, 2024 — classified as 1 injury, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Pain2
- Dyspareunia1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE PATIENT HAD SURGERY AND WAS DIAGNOSED WITH VAGINAL BLEEDING AND INABILITY TO HAVE SEXUAL INTERCOURSE. IT WAS REPORTED THAT REOPERATION WAS DONE UNDER ANESTHESIA.
Patient problems: Dyspareunia; Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 18995376 ↗MalfunctionMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE PATIENT HAD BEEN FEELING PAIN FOLLOWING IMPLANTATION IN 2015.
Patient problems: Pain
MAUDE report 13639937 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.