MAUDE Adverse Event Report: UNKNOWN CENTRAL LINE DRESSING CHANGE KIT - NON ADHERENT PAD COMPONENT; CENTRAL VENOUS CATHETER DRESSING CHANGE KIT

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

Patient Problems Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Cough (4457)

Event Date 07/06/2022

Event Type  Injury  

Event Description

Patient with a known latex allergy inadvertently used a latex-containing product on the skin and experienced sick feeling, congestion, coughing, sneezing, trouble breathing.

• Brand Name: CENTRAL LINE DRESSING CHANGE KIT - NON ADHERENT PAD COMPONENT
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 14958409
• MDR Text Key: 295671528
• Report Number: MW5110767
• Device Sequence Number: 1
• Product Code: PEZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2022
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female