K-Pack II KN-3013RBKTRecalls & reported problems
Terumo Europe NV · K-Pack II Needle · Class 2
Data updated Oct 16, 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 05413206051045), received between Feb 3, 2020 and Feb 3, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
Device problems
- Break1
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent
THE USER FACILITY REPORTED THAT THERE ONE OF TWO ELRABIE PREMIER LIGHT-LC NEEDLES ENVELOPE WAS CROOKED AND BENT DURING THE PROCEDURE (INJECTION) AND EVENTUALLY CAME OFF THE HUB. THE OTHER NEEDLE WAS FINE. ADDITIONAL INFORMATION WAS RECEIVED 05JANUARY2020: PATIENT CONDITION: SEEMS TO BE NO IMPACT ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED 17JANUARY2020: THE PROCEDURE OUTCOME WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO IMPACT ON THE PATIENT OR USER. PATIENT WAS NOT HARMED. IT WAS TOLD BY THE USER THAT THE NEEDLE BECAME BENT AND WAS BROKEN BUT IT DID NOT REMAIN IN THE SKIN. ALSO, IT DID NOT LEAVE ANY WOUND, EDEMA OR PAIN ON THE PATIENT'S FACE. DURING THE PROCEDURE, THE NEEDLE BECAME BENT AND BROKE, IT FELL OFF THE HUB, AND DID NOT REMAIN IN THE SKIN. DURING THE PROCEDURE, AS THE NEEDLE BROKE, THE DOCTOR OPENED ANOTHER NEEDLE AND THE PATIENT WAS NOT SHAKEN. ELRABIE PREMIER LIGHT-LC: CROSS-LINKED SODIUM HYALURONATE 23 MG/ML IS THE MAIN INGREDIENT OF THE PRODUCT, WHICH IS USED FOR WRINKLE-ENHANCEMENT AND HAS A VISCOSITY OF 25~35PA.S.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9661441 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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