MAUDE Adverse Event Report: BIODERM, INC. MENS LIBERTY ACUTE WITH CATHGRIP

Model Number	BIO2102610
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that an uncircumcised male patient had an external urinary drainage system applied to the glans of his penis when the penis and foreskin developed significant edema and fluid overload.The facility reported that the penis appeared with purple blister areas.The urologist evaluated the patient, removed the external urinary drainage system and inserted a #16 silicone foley catheter.The sample was not returned to the manufacturer for evaluation.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that an uncircumcised male patient had an external urinary drainage system applied to his penis when he experienced an adverse event and required a foley catheter.

• Brand Name: MENS LIBERTY ACUTE WITH CATHGRIP
• Common Device Name: MENS LIBERTY ACUTE WITH CATHGRIP
• Manufacturer (Section D): BIODERM, INC.; 12320 73rd court n; largo FL 33773
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14550613
• Report Number: 1417592-2022-00070
• Device Sequence Number: 6774229
• Product Code: NOA
• UDI-Device Identifier: 00653599000847
• UDI-Public: 00653599000847
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BIO2102610
• Device Catalogue Number: BIO2102610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male