Manashil G01114Recalls & reported problems
Cook Incorporated · Manashil Sialography Set · Class 1
- 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 00827002011144), received between Jun 23, 2017 and Jun 23, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
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.
MalfunctionJun 23, 2017Leak/Splash; Leak/Splash
INTERNATIONAL CUSTOMER REPORTS THAT A PATIENT WAS UNDERGOING A SIALOGRAPHY. A LEAK WAS NOTED IN THE MANASHIL SIALOGRAPHY CATHETER. A REPLACEMENT DEVICE WAS OBTAINED TO COMPLETE THE PROCEDURE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6665799 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.