MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; URINAL,MALE,SUPREME

Catalog Number DYND80235S

Device Problem Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Type of Device: URINAL,MALE,SUPREME
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 7723089
• MDR Text Key: 115124209
• Report Number: 1417592-2018-00074
• Device Sequence Number: 1
• Product Code: FNP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND80235S
• Device Lot Number: 308-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 64