MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-02-14 for EXO-CATHETER DYND12302 * manufactured by Medline Industries, Inc..
[15714324]
Reportedly the dermis on the patient's skin became irritated and their penis became swollen while using an exo-catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2003-00004 |
| MDR Report Key | 444752 |
| Report Source | 07 |
| Date Received | 2003-02-14 |
| Date of Report | 2003-02-14 |
| Date of Event | 2003-01-15 |
| Date Added to Maude | 2003-02-27 |
| 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 |
| Manufacturer Contact | ANDREA HAFERKAMP |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXO-CATHETER |
| Generic Name | EXO-CATHETER |
| Product Code | EXJ |
| Date Received | 2003-02-14 |
| Model Number | DYND12302 |
| Catalog Number | * |
| Lot Number | 640209 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 433730 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US |
| Baseline Brand Name | EXO-CATHETER |
| Baseline Model No | DYND12302 |
| Baseline Device Family | DN17 |
| 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. Other | 2003-02-14 |