MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-01-21 for MEDIUM FREEDOM CATHETER 26-08200 manufactured by Mentor Urology, Inc..
[88236]
A report was called in for the pt stating that the "pt [has] extreme problems keeping catheters on and sometimes sees skin redness at adhesive site. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183558-1998-00002 |
| MDR Report Key | 144861 |
| Report Source | 05 |
| Date Received | 1998-01-21 |
| Date of Report | 1997-12-05 |
| Date Mfgr Received | 1997-12-05 |
| Date Added to Maude | 1998-01-22 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIUM FREEDOM CATHETER |
| Generic Name | LATEX MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 1998-01-21 |
| Model Number | NA |
| Catalog Number | 26-08200 |
| Lot Number | NI |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 141244 |
| Manufacturer | MENTOR UROLOGY, INC. |
| Manufacturer Address | 1499 W RIVER RD N MINNEAPOLIS MN 55411 US |
| Baseline Brand Name | FREEDOM CATH - MEDIUM |
| Baseline Generic Name | MALE EXTERNAL CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 26-08200 |
| Baseline ID | NA |
| Baseline Device Family | MALE EXTERNAL CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 54 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-01-21 |