MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-07-20 for CHAIT PERCUTANEOUS CECOSTOMY CATHETER TDCS-100 manufactured by Cook Inc.
[114608304]
This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[114608305]
It was reported a patient returned to the hospital due to a chait percutaneous cecostomy catheter trap door being broken. Further clarification determined the chait catheter was leaking and that the trap door was not broken but rather "there seems to be black staining under the door". The customer reported it is unknown when the device was initially implanted and for how long it had been in place before the patient returned to the hospital. The device was removed and replace with a new device without incident. As reported, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02009 |
| MDR Report Key | 7707342 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-20 |
| Date of Report | 2018-11-30 |
| Date Mfgr Received | 2018-11-02 |
| Date Added to Maude | 2018-07-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAIT PERCUTANEOUS CECOSTOMY CATHETER |
| Generic Name | EXD IRRIGATOR, OSTOMY |
| Product Code | EXD |
| Date Received | 2018-07-20 |
| Returned To Mfg | 2018-08-14 |
| Catalog Number | TDCS-100 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-20 |