MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-09-17 for FREEDOM CATHETER 26-08400 manufactured by Mentor Urology, Inc..
[103852]
Patient normally uses a type of catheter that is designed so that no adhesive comes in contact with the skin. When his caretaker went to the pharmacy to get a supply of these catheters, she was told that they were no longer being made by this mfr. (note: the catheter is still being made and sold by this mfr. ) instead, the pharmacist supplied caretaker with self-adhesive catheters. According to the caretaker, "she tried the catheter but when she went to take it off it tore his skin and made it bleed very bad. She was unable to take off the left over adhesive on his penis and began to use alcohol, (which) made it hurt a lot. She then decided to take him to the dr to be seen, but the dr was very upset and couldn't believe they had given her catheter with adhesive on them. The dr's concern... Was because patient on coumadin and he should not be bleeding at all. The dr wants patient's caretaker to apply the hydrocortisone/antibacterial cream and to keep the penis packed in gauze. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183558-1998-00020 |
| MDR Report Key | 187514 |
| Report Source | 00 |
| Date Received | 1998-09-17 |
| Date of Report | 1998-08-19 |
| Date Mfgr Received | 1998-08-19 |
| Device Manufacturer Date | 1998-06-01 |
| Date Added to Maude | 1998-09-18 |
| 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 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEDOM CATHETER |
| Generic Name | LATEX MALE EXTERNAL CATHETER |
| Product Code | EXJ |
| Date Received | 1998-09-17 |
| Model Number | NA |
| Catalog Number | 26-08400 |
| Lot Number | 8579 |
| 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 | 182264 |
| Manufacturer | MENTOR UROLOGY, INC. |
| Manufacturer Address | 1499 WEST RIVER RD., N. MINNEAPOLIS MN 55411 US |
| Baseline Brand Name | FREEDOM CATH - LARGE |
| Baseline Generic Name | MALE EXTERNAL CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 26-08400 |
| 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 | 1998-09-17 |