Welch Allyn, Inc. 901071 (REF 410144)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00732094214109), received between May 12, 2017 and Jul 20, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Break; Break

  HILLROM RECEIVED A REPORT FROM A THE ACCOUNT THAT THE VAGINAL SPECULUM BROKE INSIDE OF A PATIENT DURING A ROUTINE EXAM. THERE WAS NO SERIOUS PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196105 ↗
• MalfunctionSep 14, 2020Fracture; Fracture

  HILLROM RECEIVED A REPORT FROM A THE ACCOUNT THAT THE VAGINAL SPECULUM BROKE INSIDE OF A PATIENT DURING A ROUTINE EXAM. THERE WAS NO SERIOUS PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 10528802 ↗
• MalfunctionSep 2, 2020Fracture; Fracture

  HILLROM RECEIVED A REPORT FROM A THE ACCOUNT THAT THE VAGINAL SPECULUM BROKE INSIDE OF A PATIENT DURING A ROUTINE EXAM. THERE WAS NO SERIOUS PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10481891 ↗
• MalfunctionMay 12, 2017Fracture; Fracture

  WELCH ALLYN RECEIVED A REPORT STATING, KLEENSPEC 590 SERIES DISPOSABLE VAGINAL SPECULUM BROKE WHILE BEING USED ON A PATIENT DURING A PELVIC EXAM. THE SPECULUM WAS EXAMINED BY THE PHYSICIAN PRIOR TO USE AND NO VISIBLE CRACKS WERE NOTED. THE PHYSICIAN INSERTED THE SPECULUM INTO THE PATIENT'S VAGINA AND IMMEDIATELY UPON OPENING OF THE SPECULUM, THE UPPER BLADE SHATTERED. APPROXIMATELY HALF OF THE LEFT SIDE OF THE UPPER BLADE BROKE OFF OF THE SPECULUM. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT'S VAGINA. THE PATIENT SUSTAINED AN APPROXIMATE 1 TO 2 CM VAGINAL WALL LACERATION FROM THE SHARP EDGE OF THE BROKEN BLADE. PRESSURE WAS APPLIED AND THE BLEEDING SUBSIDED. THE PATIENT RECOVERED WITHOUT FURTHER TREATMENT OR INCIDENT.

  Patient problems: Laceration(s); Vaginal Mucosa Damage

  MAUDE report 6562897 ↗