MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2005-11-11 for MALECOT RUSSEL GASTROSTOMY CATHETER ULT10.2-NT-23-P-NS- manufactured by Cook, Inc..
[16830939]
Catheter was placed in an outpt in 2005. It was spontaneously exited on the same day. The physician felt this situation occurred due to the softer material of the tubing. A replacement was used.
Patient Sequence No: 1, Text Type: D, B5
[16986100]
Evaluation: the device was returned in a used condition. An examination found the inner catheter slightly elongated near the black indicator line. During testing, the inner catheter separated from its bonded position at the distal tip easily when pulled. An examination of this area found no evidence that the tubing was properly bonded at time of manufacture.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2005-00296 |
| MDR Report Key | 755673 |
| Report Source | 01,05,08 |
| Date Received | 2005-11-11 |
| Date of Report | 2005-10-13 |
| Date of Event | 2005-09-28 |
| Date Facility Aware | 2005-09-28 |
| Report Date | 2005-10-13 |
| Date Mfgr Received | 2005-10-13 |
| Date Added to Maude | 2006-08-31 |
| 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 |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALECOT RUSSEL GASTROSTOMY CATHETER |
| Generic Name | CATHETER |
| Product Code | EZK |
| Date Received | 2005-11-11 |
| Returned To Mfg | 2005-11-01 |
| Model Number | NA |
| Catalog Number | ULT10.2-NT-23-P-NS- |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 743511 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US |
| Baseline Brand Name | MALECOT RUSSEL GASTROSTOMY CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | ULT10.2-NT-23-P-NS- |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-11-11 |