PRONOVA 3702HRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031004597), received between May 22, 2019 and Jun 3, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS VERY EASY TO BREAK. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10113813 ↗
• MalfunctionMay 22, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON REPORTED THAT THE SUTURE IS FRAGILE, EASILY BREAK OR DETACH FROM THE NEEDLE, SOMETIMES EVEN WHEN NOT STARTING TO SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633498 ↗
• MalfunctionMay 22, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON REPORTED THAT THE SUTURE IS FRAGILE, EASILY BREAK OR DETACH FROM THE NEEDLE, SOMETIMES EVEN WHEN NOT STARTING TO SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633497 ↗
• MalfunctionMay 22, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON REPORTED THAT THE SUTURE IS FRAGILE, EASILY BREAK OR DETACH FROM THE NEEDLE, SOMETIMES EVEN WHEN NOT STARTING TO SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633496 ↗
• MalfunctionMay 22, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON REPORTED THAT THE SUTURE IS FRAGILE, EASILY BREAK OR DETACH FROM THE NEEDLE, SOMETIMES EVEN WHEN NOT STARTING TO SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633495 ↗
• MalfunctionMay 22, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON REPORTED THAT THE SUTURE IS FRAGILE, EASILY BREAK OR DETACH FROM THE NEEDLE, SOMETIMES EVEN WHEN NOT STARTING TO SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633494 ↗
• MalfunctionMay 22, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON REPORTED THAT THE SUTURE IS FRAGILE, EASILY BREAK OR DETACH FROM THE NEEDLE, SOMETIMES EVEN WHEN NOT STARTING TO SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633493 ↗
• MalfunctionMay 22, 2019Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SURGEON REPORTED THAT THE SUTURE IS FRAGILE, EASILY BREAK OR DETACH FROM THE NEEDLE, SOMETIMES EVEN WHEN NOT STARTING TO SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633492 ↗