MAUDE Adverse Event Report: BIODERM, INC. MEN'S LIBERTY ACUTE WITH CATHGRIP; EXTERNAL CATHETER

Model Number	BIO2102610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No lot number was provided to review manufacturing records.Further information was requested by the distributor multiple times.Bioderm requested further information on product use from the contact provided.No further information was received.Will update report if more information is acquired.Distributor also submitted this report as a medwatch.
Event or Problem Description
Distributor informed bioderm of a complaint they received by one of their customers (hospital).The hospital reported an uncircumcised male patient developed significant edema, fluid overload, and purple blister areas on his penis while using men's liberty acute.They reported the patient was evaluated by the urologist, who removed the mla and inserted a foley catheter.

• Brand Name: MEN'S LIBERTY ACUTE WITH CATHGRIP
• Common Device Name: EXTERNAL CATHETER
• Manufacturer (Section D): BIODERM, INC.; 12320 73rd court n; largo FL 33773
• Manufacturer Contact: 12320 73rd court n; largo, FL 33773
• MDR Report Key: 14859975
• Report Number: 3001949129-2022-00006
• Device Sequence Number: 14763735
• 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): 06/29/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: BIO2102610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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