PROLENE D5981Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031025875), received between Apr 19, 2018 and Dec 8, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUNG LACERATION REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIOR TO THE PROCEDURE, THE PATIENT WAS RECEIVING BIOLOGICS, STEROIDS, AND IMMUNOSUPPRESSANTS FOR RHEUMATOID ARTHRITIS AND INTERSTITIAL PNEUMONIA. THE PATIENT WAS TRANSPORTED BY AMBULANCE TO THE HOSPITAL WITH A CHIEF COMPLAINT OF RESPIRATORY DISCOMFORT. HE WAS DIAGNOSED WITH RIGHT PNEUMOTHORAX, AND CHEST TUBE DRAINAGE WAS PERFORMED. BECAUSE OF CONTINUOUS AIR-LEAKAGE, SURGICAL TREATMENT WAS PLANNED. CT SHOWED DIFFUSE EMPHYSEMATOUS CHANGE AND HONEYCOMB LUNG, AND IT WAS DIFFICULT TO IDENTIFY THE OBVIOUS CULPRIT LESION. AT THE FIRST OPERATION, THERE WAS A LACERATION OF ABOUT 1 CM IN THE DORSAL SIDE OF LOWER LOBE S6. THE SAME SITE WAS SUTURED AND CLOSED, AND FREE PERICARDIAL FAT TISSUE WAS FILLED, BUT IT RECURRED ON DAY 3. B6 WAS FILLED WITH EWS FOR THE SECOND TIME, BUT IT RECURRED ON THE SECOND DAY. THE THIRD TIME, PGA SEAT AND FIBRIN GLUE WERE ALTERNATELY FILLED FROM THE S6 LACERATION SITE AND FILLED WITH A PEDICLED INTERCOSTAL MUSCLE FLAP, BUT IT RECURRED ON THE 4TH DAY. ADHESION THERAPY WAS PERFORMED DURING THE INTERVAL OF SURGERY, BUT IT WAS INEFFECTIVE. OMENTOPEXY WA

  Patient problems: Laceration(s)

  MAUDE report 15944103 ↗
• MalfunctionApr 19, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ON (B)(6) 2018, A STAFF MEMBER OF THE HOSPITAL WAS PRICKED HIS/HER FINGER ON A NEEDLE WHICH WAS PROTRUDED FROM AN UNOPENED PACKAGE WHILE HE/SHE WAS WORKING IN THE STOCK ROOM. THE INJURED STAFF WAS NOT INFECTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7445873 ↗