MAUDE Adverse Event Report: DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIP.CO. COMPASS HEALTH BRANDS; NEBULIZER

Model Number NEB-RITE4

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Burn(s) (1757)

Event Date 06/03/2020

Event Type  Injury  

Event Description

Letter of representation received: claimant sustained personal injuries as the result of an incident, whereby our client used the product and was burned.As a result of this incident, a claim is being made against your insured.

• Brand Name: COMPASS HEALTH BRANDS
• Type of Device: NEBULIZER
• Manufacturer (Section D): DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIP.CO.; part b,3rd f, block a, wentang; longhua road zhouwu dongcheng; dongguan city, guangdong province 52300 0; CH 523000
• MDR Report Key: 10704897
• MDR Text Key: 212097621
• Report Number: 3012316249-2020-00032
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NEB-RITE4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2020
• Distributor Facility Aware Date: 09/29/2020
• Date Report to Manufacturer: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other