MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2003-10-22 for MALECOT RUSSEL GASTROSTOMY CATHETER ULT10.2-NT-25-P-NS-RMGS manufactured by Cook, Inc..
[331808]
The patient developed cerebral hemorrhage in 2003, and underwent the peg due to dysphagy as sequela of the cerebral hemorrhage at a hospital, where the device was first placed 4 months earlier. Approximately 100 days after placement, the catheter came out spontaneously due to the closure of the malecot. The physician advises the catheter was flushed after each drug administration. Minor swelling was observed on the catheter shaft, approximately 7cm from the tip. The patient underwent the second peg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2003-00185 |
| MDR Report Key | 492249 |
| Report Source | 01,06 |
| Date Received | 2003-10-22 |
| Date of Report | 2003-09-26 |
| Date of Event | 2003-09-05 |
| Date Facility Aware | 2003-09-05 |
| Report Date | 2003-09-26 |
| Date Mfgr Received | 2003-09-26 |
| Date Added to Maude | 2003-10-31 |
| 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 | 2003-10-22 |
| Model Number | NA |
| Catalog Number | ULT10.2-NT-25-P-NS-RMGS |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 480948 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US |
| Baseline Brand Name | MALECOT RUSSEL GASTROSTOMY CATHETER |
| Baseline Generic Name | NA |
| Baseline Model No | NA |
| Baseline Catalog No | ULT10.2-NT-25-P-NS-RMGS |
| Baseline ID | NA |
| Baseline Device Family | CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-22 |