MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-10 for URINAL MALE DELUXE TRANSLUCENT manufactured by Medegen Medical Products.
[64290055]
Patient Sequence No: 1, Text Type: N, H10
[64290056]
Urinals have rough edges and many ridges on the inside causing a bladder stone to get stuck in the ridge and having to cut the urinal to retrieve the stone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6236588 |
| MDR Report Key | 6236588 |
| Date Received | 2017-01-10 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-12-01 |
| Report Date | 2016-12-09 |
| Date Reported to FDA | 2016-12-09 |
| Date Reported to Mfgr | 2016-12-09 |
| Date Added to Maude | 2017-01-10 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINAL MALE DELUXE TRANSLUCENT |
| Generic Name | URINAL |
| Product Code | FNP |
| Date Received | 2017-01-10 |
| Lot Number | 12951521 |
| ID Number | H140D-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS |
| Manufacturer Address | 209 MEDEGEN DR. GALLAWAY TN 38036 US 38036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-10 |