ProACT - Blunt Trocar 750042Recalls & reported problems
Uromedica Inc · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00180668000137), received between Mar 16, 2021 and Jun 21, 2022 — classified as 6 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (3 reports).
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
Device problems
- Use of Device Problem3
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
- Malposition of Device1
- Patient Device Interaction Problem1
Patient problems
- Internal Organ Perforation6
- Fluid Discharge2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2022Use of Device Problem; Use of Device Problem
INTEROPERATIVE BLADDER PERFORATION (PATIENT'S LEFT SIDE) DURING A PROACT IMPLANTATION PROCEDURE. THE BILATERIAL IMPLANTATION PROCEDURE WAS COMPLETED SUCCESSFULLY. PERFORATION TREATED WITH TEMPORARY CATHETERIZATION.
Patient problems: Internal Organ Perforation
MAUDE report 14756068 ↗InjuryFeb 1, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
INTEROPERATIVE BLADDER PERFORATION (PATIENT'S RIGHT SIDE) IN A PROACT PATIENT. PERFORATION TREATED WITH TEMPORARY CATHETERIZATION. RIGHT-SIDE IMPLANTATION WAS NOT COMPLETED AND WILL BE RE-ATTEMPTED IN 2-3 MONTHS.
Patient problems: Internal Organ Perforation
MAUDE report 13419227 ↗InjuryNov 24, 2021Use of Device Problem; Use of Device Problem
BLADDER PERFORATION IN A PROACT PATIENT. THE PATIENT'S BLADDER WAS PERFORATED WITH THE BLUNT-TIPPED TROCAR DURING DILATION FOR THE PATIENT'S LEFT-SIDE PROACT. THE PERFORATION WAS TREATED WITH TEMPORARY CATHETERIZATION. THE PATIENT'S RIGHT-SIDE PROACT WAS IMPLANTED WITHOUT INCIDENT.
Patient problems: Internal Organ Perforation
MAUDE report 12869240 ↗InjuryAug 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
RIGHT-SIDE BLADDER PERFORATION DURING A PROACT IMPLANTATION PROCEDURE. PATIENT SUCCESSFULLY IMPLANTED. RIGHT-SIDE PROACT BALLOON WAS PLACED LATERAL TO THE PERFORATION AND DISTAL TO THE BLADDER NECK. LEFT-SIDE IMPLANT WAS PLACED NORMALLY. PERFORATION WAS TREATED WITH A FOLEY CATHETER.
Patient problems: Fluid Discharge; Internal Organ Perforation
MAUDE report 12367475 ↗InjuryJun 14, 2021Use of Device Problem; Use of Device Problem
BLADDER PERFORATION DURING A PROACT IMPLANTATION PROCEDURE. PATIENT WAS TREATED WITH A CATHETER.
Patient problems: Fluid Discharge; Internal Organ Perforation
MAUDE report 11995718 ↗InjuryMar 16, 2021Malposition of Device; Patient Device Interaction Problem; Malposition of Device; Patient Device Interaction Problem
BLADDER PERFORATION DURING A PROACT IMPLANTATION PROCEDURE. PERFORATION WAS TREATED WITH A FOLEY CATHETER AND ANTIBIOTICS.
Patient problems: Internal Organ Perforation
MAUDE report 11497092 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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