Proximate PXR35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705036002666), received between Sep 28, 2023 and Sep 28, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanics Altered” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGEON USED THE PXW35 SKIN STAPLER TO APPOSE WOUND EDGES POST-OPERATIVELY. SURGEON COMPLAINED THE FOLLOWING DAY THAT SOME OF THE CLIPS HAD BECOME UNDONE. THE SURGEON NEEDED TO TOUCH UP THE SURGICAL WOUND CLOSURE USING A SUTURE. THE SURGEON OBSERVED UNDOING OF STAPLES ON SURGICAL WOUND. THIS WAS CORRECTED WITH SUTURES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Wound Dehiscence

  MAUDE report 17833147 ↗