MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-20 for VOLLRATH H140D-01 UNK manufactured by Medegen Medical Products.
[294250]
Pt's spouse told the nursing staff that when pt used the urinal, it cut them. Bloody drainage noted at base of penis and foreskin areas. Cold packs applied immediately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 497235 |
| MDR Report Key | 497235 |
| Date Received | 2003-11-20 |
| Date of Report | 2003-11-17 |
| Date of Event | 2003-11-12 |
| Report Date | 2003-11-17 |
| Date Reported to FDA | 2003-11-20 |
| Date Reported to Mfgr | 2003-11-20 |
| Date Added to Maude | 2003-11-26 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOLLRATH |
| Generic Name | MALE URINAL |
| Product Code | FNP |
| Date Received | 2003-11-20 |
| Model Number | H140D-01 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 485989 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS |
| Manufacturer Address | 209 MEDEGEN DRIVE GALLAWAY TN 38036 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-11-20 |