MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-04 for MEDLINE URINAL DYND80235S manufactured by Medline.
[56909644]
Patient was using urinal as intended, small skin tear to penis. Patient reported the issue and wasn't serious injured, antiseptics applied and skin follow ups showed no lasting injury. Dates of use: (b)(6) 2016. Diagnosis or reason for use: patient urinal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065224 |
| MDR Report Key | 6003013 |
| Date Received | 2016-10-04 |
| Date of Report | 2016-10-04 |
| Date of Event | 2016-10-03 |
| Date Added to Maude | 2016-10-06 |
| 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 | 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 | 0 |
| Brand Name | MEDLINE URINAL |
| Generic Name | MEDLINE URINAL |
| Product Code | FNP |
| Date Received | 2016-10-04 |
| Model Number | DYND80235S |
| Catalog Number | DYND80235S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-04 |