Medline Industries, Inc. DYNJ47948BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889942650231), received between Oct 24, 2018 and Nov 21, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 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.

• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SUSTAINED BURN (DISTAL TO THE SURGICAL SITE) FROM THE CAUTERY PENCIL THAT SIGNALED IN-USE ON GENERATOR DESPITE THE ROCKER-SWITCH ON THE CAUTERY PENCIL NOT ACTIVATED.

  Patient problems: Burn(s)

  MAUDE report 8096106 ↗
• MalfunctionOct 24, 2018Improper or Incorrect Procedure or Method

  CAUTERY PENCIL FROM MAJOR ORTHO PACK WITH LOT NO 18HBK660 SIGNALED "IN USE" EVEN WHEN BUTTON WAS NOT PRESSED. CAUTERY PENCIL UNPLUGGED FROM ELECTRICAL UNIT. NEW PENCIL FROM OR STOCK PASSED TO FIELD. ALLEGED CUT/BURN TO PATIENT'S ARM.

  Patient problems: Injury

  MAUDE report 8000226 ↗