MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2018-07-26 for DYND80235S manufactured by Medline Industries Inc..
[115124209]
It was reported that the patient experienced a cut to his penis from a sharp edge on a urinal. Reportedly, the patient was being assisted by a nurse while in an emergency department (ed). The urinal was being held by the nurse. Per the patient's family member, the nurse "must have pushed really hard. " the reported sharp edge was located on the piece that connects the lid to the urinal. The patient was admitted to the hospital from the ed due to the unidentified complaint that initially brought him to the facility. No information related to ed diagnostics or ed treatments were reported to the manufacturer. Reportedly, the patient experienced bruising, swelling, and continued bleeding to his penis as he takes an unidentified "blood thinner. " the family member noted that a foley catheter was inserted as the patient experienced difficulty to "empty his bladder. " this foley catheter was removed when the patient was discharged from the facility. According to the family member, the patient has no longer experienced issues with bleeding or urination. No sample was returned to the manufacturer for evaluation. Photos of the reported sample were submitted to the manufacturer. The photos were reviewed and the manufacturer is unable to determine if there are any sharp edges. The reported product issue was not confirmed and root cause could not be determined. Due to the reported incident and the need for medical intervention, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[115124210]
It was reported that the patient experienced a cut to his penis from a sharp edge on a urinal. A foley catheter was reportedly inserted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00074 |
| MDR Report Key | 7723089 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2018-07-26 |
| Date of Report | 2018-07-26 |
| Date of Event | 2018-05-02 |
| Date Mfgr Received | 2018-07-19 |
| Date Added to Maude | 2018-07-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | URINAL,MALE,SUPREME |
| Product Code | FNP |
| Date Received | 2018-07-26 |
| Catalog Number | DYND80235S |
| Lot Number | 308-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-26 |