MAUDE Adverse Event Report: LAERDAL MEDICAL A/S LAERDAL V-VAC; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number J52

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/27/2022

Event Type  Injury  

Event Description

Nasal bleeding.Fda safety report id# (b)(4).

• Brand Name: LAERDAL V-VAC
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): LAERDAL MEDICAL A/S
• MDR Report Key: 15462217
• MDR Text Key: 300356798
• Report Number: MW5112156
• Device Sequence Number: 1
• Product Code: BTA
• 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
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: J52
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White