MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-07-15 for CONTINENT ILEO POUCH CATHETER 30-7025 manufactured by Mentor Corp - Minnesota Div.
[19540722]
According to the info the pt states the tip of the last two ileo catheters they have received and used have broken off in their internal pouch. Both occurences required surgery with general anesthesia and iv antibiotics. They may require additional surgery to locate/remove the second tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183558-2004-00013 |
| MDR Report Key | 611270 |
| Report Source | 04 |
| Date Received | 2004-07-15 |
| Date of Report | 2004-06-15 |
| Date Facility Aware | 2004-06-15 |
| Date Mfgr Received | 2004-06-15 |
| Date Added to Maude | 2005-06-08 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JEANNE WYATT |
| Manufacturer Street | 1525 W RIVER RD N |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6122874222 |
| Manufacturer G1 | MENTOR CORP - MINNESOTA DIV |
| Manufacturer Street | 1615 W. RIVER RD N |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55411 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTINENT ILEO POUCH CATHETER |
| Generic Name | ILEO CATHETER |
| Product Code | KPH |
| Date Received | 2004-07-15 |
| Model Number | 30-7025 |
| Catalog Number | 30-7025 |
| Lot Number | NI |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 601066 |
| Manufacturer | MENTOR CORP - MINNESOTA DIV |
| Manufacturer Address | * MINNEAPOLIS MN * US |
| Baseline Brand Name | CONTINENT ILEO POUCH CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 30-7025 |
| Baseline ID | NA |
| Baseline Device Family | ILEO POUCH CATHETER |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2004-07-15 |