MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1999-03-30 for TRIPLE PORT GASTROSTOMY CATHETER E3316, E3314 manufactured by Rusch, Inc..
[129905]
It is alleged that there are tears in the tubing, causing leakage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2429473-1999-00017 |
| MDR Report Key | 217073 |
| Report Source | 08 |
| Date Received | 1999-03-30 |
| Date of Report | 1999-03-30 |
| Date of Event | 1999-01-02 |
| Date Mfgr Received | 1999-03-18 |
| Date Added to Maude | 1999-04-06 |
| 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 |
| 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 | 1999-03-30 |
| Model Number | NA |
| Catalog Number | E3316, E3314 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 210556 |
| Manufacturer | RUSCH, INC. |
| Manufacturer Address | 2450 MEADOWBROOK PKWY. DULUTH GA 30096 US |
| Baseline Brand Name | TRIPLE PORT GASTROSTOMY CATHETER |
| Baseline Generic Name | GASTROSTOMY CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | E3316, E3314 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-03-30 |