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

Model Number	NEB-RITE4
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Due to distributors reporting mdr directly on the maude data system on the fda official website without informing the sales department of the informati on, the sales department did not regularly collect feedback information from distributors and did not realize the need to proactively check whether the co mpany has mdr on the maude data system on the fda official website.They only believed that only information directly complained to our company by cust omers needs to be processed, resulting in the company not being aware of this mdr.The mdr report is as follows: mdr report #3012316249-2020-00032.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.Received a letter from the representative: the claimant suffered personal injury due to an incident in which our customer used the product and was burned.As a result of this incident, a claim is being made against your insured.Mdr report # 3012316249-2020-00032 occurred in 2020, and now it has expired.For details, please refer to customer survey record form no: (b)(4).

• Brand Name: COMPASS HEALTH BRANDS
• Common Device Name: NEBULIZER
• Manufacturer (Section D): DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIP.CO; part b,3rd f, block a, wentang; longhua road zhouwu dongcheng; dongguan, guangdong 52300 0; CH 523000
• Manufacturer (Section G): SALES@STRONGHEALTH.COM.CN; part b,3rd f, block a, wentang; longhua road zhouwu dongcheng; dongguan, guangdong 52300 0; CH 523000
• Manufacturer Contact: jianjun wang ; part b,3rd f, block a, wentang; longhua road zhouwu dongcheng; dongguan, guangdong 52300-0 ; CH 523000
• MDR Report Key: 20828506
• Report Number: 3011189029-2024-00001
• Device Sequence Number: 8729684
• Product Code: CAF
• UDI-Device Identifier: 00092237619803
• UDI-Public: (01)00092237619803
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: 3011189029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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 Expiration Date: 09/25/2021
• Device Model Number: NEB-RITE4
• Device Lot Number: OR2361808-8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2018
• Is the Device Labeled for Single Use? (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: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Unknown