MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-06 for VOLLRATH 00195 manufactured by Medegen Medical Products.
[15031546]
Four urinals were previously discovered with sharp edges. One urinal was involved in a minor injury. This incident was previously reported to fda. In the hopes of finding a safer urinal, a substitute product was ordered. This product was inspected prior to being put into patient use. Inspection revealed a sharp edge. Burr was present at the point in the opening where the two halves of the device were annealed, as well as at other points around the perimeter of the opening. The problem noted with the substitute urinal looked similar to the problem with the previous urinal. The plastic of the substitute product was a thicker plastic then the previous urinal. There is a potential for minor injury to a patient using the substitute urinal. Note: upon further investigation it was discovered that vollrath, the product manufacturer, is a division of medegen. Medegen manufactured the urinal that previously caused a minor injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 653506 |
| MDR Report Key | 653506 |
| Date Received | 2005-12-06 |
| Date of Report | 2005-12-06 |
| Date of Event | 2005-12-06 |
| 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 | VOLLRATH |
| Generic Name | MALE URINAL |
| Product Code | FNP |
| Date Received | 2005-12-06 |
| Model Number | 00195 |
| Catalog Number | 00195 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 642969 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS |
| Manufacturer Address | 206 MEDEGEN DR. GALLOWAY TN 38036 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-12-06 |