MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for URICLIP H143-01 manufactured by Medegen Medical Products.
[174509691]
Uriclip urinal holders have very sharp edges where they were broken off the manufacturing mold. Noted on 6/8 devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9574352 |
| MDR Report Key | 9574352 |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-26 |
| Date of Event | 2019-12-13 |
| Report Date | 2019-12-26 |
| Date Reported to FDA | 2019-12-26 |
| Date Reported to Mfgr | 2020-01-10 |
| Date Added to Maude | 2020-01-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | URICLIP |
| Generic Name | URINAL |
| Product Code | FNP |
| Date Received | 2020-01-10 |
| Model Number | H143-01 |
| Catalog Number | H143-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS |
| Manufacturer Address | 209 MEDEGEN DRIVE GALLAWAY TN 38036 US 38036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |