MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for MEDEGEN MEDICAL PRODUCT V-12 manufactured by Medegen Medical Products.
[119669620]
(b)(6) medical product - urinal with handle #v-12. Three pts have reported injury to the genital within (b)(6) health corporation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079652 |
| MDR Report Key | 7854882 |
| Date Received | 2018-09-06 |
| Date of Event | 2018-08-27 |
| Date Added to Maude | 2018-09-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 0 |
| Brand Name | MEDEGEN MEDICAL PRODUCT |
| Generic Name | URINAL |
| Product Code | FNP |
| Date Received | 2018-09-06 |
| Model Number | V-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS |
| Manufacturer Address | GALLAWAY TN US |
| Brand Name | MEDEGEN MEDICAL PRODUCT |
| Generic Name | URINAL |
| Product Code | FNP |
| Date Received | 2018-09-06 |
| Model Number | V-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS |
| Manufacturer Address | GALLAWAY TN US |
| Brand Name | MEDEGEN MEDICAL PRODUCT |
| Generic Name | URINAL |
| Product Code | FNP |
| Date Received | 2018-09-06 |
| Model Number | V-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS |
| Manufacturer Address | GALLAWAY TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-06 |