MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; CATHETER,EXTERNAL,MALE,EXO,LTX,MED,30MM

Model Number DYND12302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Tears (2516); Swelling/ Edema (4577)

Event Date 06/18/2022

Event Type  Injury  

Event Description

According to the facility the patient experienced severe edema and a rash around the glands and foreskin of the penis where skin was removed.

Manufacturer Narrative

According to the facility the patient experienced severe edema and a rash around the glands and foreskin of the penis where skin was removed.No additional information is available at this time.The sample is available but was not returned for evaluation.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.

• Brand Name: Medline
• Type of Device: CATHETER,EXTERNAL,MALE,EXO,LTX,MED,30MM
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15001393
• MDR Text Key: 295795694
• Report Number: 1417592-2022-00101
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 10080196030903
• UDI-Public: 10080196030903
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2022

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
• Device Operator: Health Professional
• Device Model Number: DYND12302
• Device Catalogue Number: DYND12302H
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/13/2022
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 104 KG