MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1998-12-15 for TRIPLE-PORT GASTROSTOMY CATHETER E3312 manufactured by Rusch, Inc..
[116495]
It has been alleged that a gastrostomy catheter was filled with 5cc of water and after one day the balloon's volume was decreased to 2cc of water and the catheter fell out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1998-00079 |
| MDR Report Key | 202310 |
| Report Source | 08 |
| Date Received | 1998-12-15 |
| Date of Report | 1998-12-14 |
| Date Mfgr Received | 1998-12-11 |
| Date Added to Maude | 1998-12-18 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIPLE-PORT GASTROSTOMY CATHETER |
| Generic Name | GASTROSTOMY CATHETER |
| Product Code | KDH |
| Date Received | 1998-12-15 |
| Model Number | NA |
| Catalog Number | E3312 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 196507 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PARKWAY DULUTH GA 30519 US |
| Baseline Brand Name | TRIPLE-PORT GASTROSTOMY CATHETERS |
| Baseline Generic Name | GASTROSTOMY CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | E3312 |
| Baseline ID | NA |
| Baseline Device Family | GASTROSTOMY CATHETER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K891371 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-12-15 |