Chait G36392Recalls & reported problems
Cook Incorporated · Chait Trapdoor Cecostomy Catheter Set · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002363922), received between Apr 13, 2017 and May 25, 2023 — classified as 2 injuries, 3 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Component Missing1
- Delivered as Unsterile Product1
- Device Contaminated During Manufacture or Shipping1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Migration or Expulsion of Device1
- Off-Label Use1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
- Peritonitis1
- Pneumoperitoneum1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 25, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Off-Label Use; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Peritonitis; Pneumoperitoneum
MAUDE report 17005880 ↗InjuryMay 19, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11850304 ↗MalfunctionJul 22, 2020Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Patient Involvement
MAUDE report 10308350 ↗MalfunctionOct 18, 2017Component Missing; Component Missing
THE CUSTOMER REPORTED THAT THE PROTRUDING PORTION OF THE DEVICE WHICH SECURES THE TRAPDOOR WAS MISSING. IT WAS CONFIRMED THAT THE CATHETER HAD TO BE REMOVED AND REPLACED, BUT THE PRODUCT ISSUE WAS REPORTEDLY NOTICED UPON THE INITIAL PLACEMENT OF THE DEVICE. NO ADVERSE EFFECTS OR OTHER COMPLICATIONS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6959177 ↗MalfunctionApr 13, 2017Break; Break
INTERNATIONAL CUSTOMER / PATIENT REPORTED THAT THE CLAMP WAS BROKEN RESULTING IN LEAKAGE OF WATER FROM THE DEVICE. THE DEVICE IMPLANT DATE WAS NOT PROVIDED. THE LEAKAGE WAS OBSERVED IN THE CONNECTING TUBE. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING UP TO THE EVENT ARE NOT KNOWN. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF TWO REPORTS BEING SUBMITTED AS THE REPORTER / PATIENT INDICATED TWO SEPARATE EVENTS. SEE MDR NUMBERS 1820334-2017-00650 AND 1820334-2017-00651 FOR EACH ASSOCIATED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6490416 ↗
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- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
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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 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.
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