MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-10 for SUPREME CLEAR URINAL WITH CLEAR COVER DYND80235S manufactured by Medline Industries Inc..
[4674993]
Patient sustained a minor cut from a urinal while in use. It is thought that the plastic on the urinal was too sharp and cut the patient's penis while trying to use the urinal. The nurse applied pressure to stop the bleeding and no additional treatment was required. ======================manufacturer response for supreme urinal/ clear w/cover, medline (per site reporter). ======================the sales rep thank me for telling him.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3893501 |
| MDR Report Key | 3893501 |
| Date Received | 2014-06-10 |
| Date of Report | 2014-06-10 |
| Date of Event | 2014-05-23 |
| Report Date | 2014-06-10 |
| Date Reported to FDA | 2014-06-10 |
| Date Reported to Mfgr | 2014-06-25 |
| Date Added to Maude | 2014-06-25 |
| 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 |
| 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 | SUPREME CLEAR URINAL WITH CLEAR COVER |
| Generic Name | URINAL |
| Product Code | FNP |
| Date Received | 2014-06-10 |
| Model Number | DYND80235S |
| Catalog Number | DYND80235S |
| Lot Number | 315104421 0271 |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-10 |