digene® HC2 DNA Collection Device 1Recalls & reported problems
Qiagen Sciences Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14053228010354), received between Sep 26, 2016 and Sep 26, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2016Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2016 (B)(6) RECEIVED A REPORT, (B)(6) FROM (B)(6) INDUSTRIAL HEALTH ASSOCIATION IN (B)(6) OF AN INCIDENT WHERE THE BRUSH HEAD BECAME DETACHED FROM THE SHAFT AND REMAINED INSIDE THE PATIENT. THE BRUSH WAS IMMEDIATELY REMOVED FROM THE PATIENT WITHOUT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5976768 ↗
Other Spatula, Cervical, Cytological devices
- Rovers® Cervex-Brush® 491461Rovers Medical Devices B.V. · Spatula, Cervical, Cytological1 report
- Rovers® Cervex-Brush® Combi 491462Rovers Medical Devices B.V. · Spatula, Cervical, Cytological1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page