MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-06-17 for MARLEN manufactured by Merlen Manufacturing & Development Co.
[300415]
Continent ileostomy catheter folded upon insertion into bcir valve on two separate occasions, with two new catheters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028747 |
| MDR Report Key | 467314 |
| Date Received | 2003-06-17 |
| Date of Report | 2003-06-17 |
| Date of Event | 2003-03-02 |
| Date Added to Maude | 2003-06-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARLEN |
| Generic Name | 30 FRENCH CURVED CATHETER |
| Product Code | KPH |
| Date Received | 2003-06-17 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 456259 |
| Manufacturer | MERLEN MANUFACTURING & DEVELOPMENT CO |
| Manufacturer Address | 5150 RICHMOND ROAD BEDFORD OH 44146 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-06-17 |