MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-01 for CLEAR ADVANTAGE 6200 * manufactured by Mentor Minnesota Inc..
[116158]
Pt has been using this brand and size of catheters for two years. The co repackaged the catheter. Pt complains that the newly packaged catheter seems smaller and has too much adhesive. When removing, it almost rips his skin off, and on one occasion, his wife had to cut the catheter off with scissors. When faciltiy called mfr, they said the only thing they changed was the packaging. Pt states this is definitely not true.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1015158 |
| MDR Report Key | 201187 |
| Date Received | 1998-12-01 |
| Date of Report | 1998-12-01 |
| Date of Event | 1998-10-01 |
| Date Added to Maude | 1998-12-14 |
| 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 |
| 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 | CLEAR ADVANTAGE |
| Generic Name | MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 1998-12-01 |
| Model Number | 6200 |
| Catalog Number | * |
| Lot Number | 10235 |
| ID Number | 081317162001 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 195422 |
| Manufacturer | MENTOR MINNESOTA INC. |
| Manufacturer Address | 1525 WEST RIVER RD NORTH MINNEAPOLIS MN 55411 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-12-01 |