MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-09-03 for CHAIT PERCUTANEOUS CECOSTOMY CATHETER TDCS-100-M manufactured by Cook, Inc..
[929253]
The chait was placed in the patient in 2008. At approx three months later, patient called the facility notifying them that the trap door broke just below the hub, in the tubing. The pt returned to the facility, and had the catheter replaced with a new one. Patient is well.
Patient Sequence No: 1, Text Type: D, B5
[7891981]
Lot number not provided by reporter. Device unknown, as the lot number was not provided. No product was returned to assist us in this investigation. Unfortunately, without the actual complaint device, we are unable to determine with certainty, how this event may have occurred. The appropriate individuals have been notified of this matter. We will continue to monitor for similar reports.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2008-00483 |
| MDR Report Key | 1149471 |
| Report Source | 05 |
| Date Received | 2008-09-03 |
| Date of Report | 2008-08-04 |
| Date of Event | 2008-06-23 |
| Date Facility Aware | 2008-08-06 |
| Report Date | 2008-08-04 |
| Date Mfgr Received | 2008-08-04 |
| Date Added to Maude | 2008-11-22 |
| 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 | RITA HARDEN, MANAGER |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| 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 | 2008-09-03 |
| Model Number | NA |
| Catalog Number | TDCS-100-M |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1290445 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-03 |