MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER,EXTERNAL,MALE,EXO,LTX,LG,35MM

Catalog Number	DYND12301
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Swelling and induration.
Additional Manufacturer Narrative
It was reported that the device was 28 mm when measured rather than 35mm.Due to this, redness and swelling occurred causing him to go to the emergency room.He received iv antiobiotics and was admitted to the hospital due to concerns of infection.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: CATHETER,EXTERNAL,MALE,EXO,LTX,LG,35MM
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19805574
• Report Number: 1417592-2024-00763
• Device Sequence Number: 18237476
• Product Code: NNX
• UDI-Device Identifier: 40080196030898
• UDI-Public: 40080196030898
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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
• Device Catalogue Number: DYND12301
• Device Lot Number: 91123120001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (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: Other
• Patient Sex: Male