MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-30 for TRANSLUCENT URINAL, HANG HANDLE & COVER H140-01 manufactured by Medegen Medical Products, Llc.
[63636725]
Patient Sequence No: 1, Text Type: N, H10
[63636726]
The urinal was leaking urine from a hole, at the base of the urinal. Three patients reported leaking urinals over the course of two days. I also talked to the distribution center in the hospital who supply the urinals to the departments and they said they seem thinner than what they used to be. Some of the urinals seem thinner in the corner where the wholes were. Manufacturer response for urinal, (brand not provided) (per site reporter): they are sending me ship material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6215528 |
| MDR Report Key | 6215528 |
| Date Received | 2016-12-30 |
| Date of Report | 2016-12-12 |
| Date of Event | 2016-12-07 |
| Report Date | 2016-12-12 |
| Date Reported to FDA | 2016-12-12 |
| Date Reported to Mfgr | 2016-12-12 |
| Date Added to Maude | 2016-12-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | TRANSLUCENT URINAL, HANG HANDLE & COVER |
| Generic Name | URINAL |
| Product Code | FNP |
| Date Received | 2016-12-30 |
| Catalog Number | H140-01 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDEGEN MEDICAL PRODUCTS, LLC |
| Manufacturer Address | 209 MEDEGEN DR. GALLAWAY TN 38036 US 38036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-30 |