MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-06 for * H140D01 manufactured by Medegen.
[425217]
Patient sustained minor cut on his penis while urinating. Examination revealed that the urinal had an edge which was sharp and burred. Upon investigation, an additional four urinals were found to have the same problem. Treated patient's cut with topical bacitracin. Healed satisfactorily. We have contacted the distributor who is filing a report with the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 653501 |
| MDR Report Key | 653501 |
| Date Received | 2005-12-06 |
| Date of Report | 2005-12-06 |
| Date of Event | 2005-12-05 |
| Report Date | 2005-12-06 |
| Date Reported to FDA | 2005-12-06 |
| Date Added to Maude | 2005-12-19 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | MALE URINAL |
| Product Code | FNP |
| Date Received | 2005-12-06 |
| Model Number | * |
| Catalog Number | H140D01 |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 642964 |
| Manufacturer | MEDEGEN |
| Manufacturer Address | 209 MEDEGEN DRIVE GALLAWAY TN 38036 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-06 |