MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1998-03-03 for SILICONE MALE EXTERNAL CATHETER 6200 manufactured by Mentor Urology, Inc..
[17487654]
As reported to co by the pt, the last batch of catheters "is too sticky... Ends up taking off skin. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183558-1998-00009 |
| MDR Report Key | 153705 |
| Report Source | 04 |
| Date Received | 1998-03-03 |
| Date of Report | 1998-02-03 |
| Date Mfgr Received | 1998-02-03 |
| Device Manufacturer Date | 1997-09-01 |
| Date Added to Maude | 1998-03-04 |
| 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 |
| 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 | SILICONE MALE EXTERNAL CATHETER |
| Generic Name | CATHETER |
| Product Code | EXJ |
| Date Received | 1998-03-03 |
| Returned To Mfg | 1998-02-20 |
| Model Number | NA |
| Catalog Number | 6200 |
| Lot Number | 5656 |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 149733 |
| Manufacturer | MENTOR UROLOGY, INC. |
| Manufacturer Address | 1499 WEST RIVER RD NORTH MINNEAPOLIS MN 55411 US |
| Baseline Brand Name | SILICONE MALE EXTERNAL CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 6200 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-03-03 |