MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; COMPRESSOR,NEBULIZER,AEROMIST COMPACT

Model Number MDR107002E

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer her child is unable to use his required nebulizer due to the device experiencing 'melting on the top, bottom, and all around the seams of the device'.The customer stated that the device has been stored and maintained in a dry area and has been used as directed.The customer stated that there was no noted smoke or fire but that the device gets 'abnormally hot' when in use.The device was purchased from a local pharmacy in (b)(6) 2022 and is used daily to provide nebulizer treatments for the customer's child.The device was returned for evaluation, however, a definitive root cause could not be determined at this time.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.

Event Description

According to the customer her child is unable to use his required nebulizer due to the device experiencing 'melting on the top, bottom, and all around the seams of the device.'.

• Brand Name: Medline
• Type of Device: COMPRESSOR,NEBULIZER,AEROMIST COMPACT
• 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: 16086336
• MDR Text Key: 306528720
• Report Number: 1417592-2023-00001
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 40080196320999
• UDI-Public: 40080196320999
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MDR107002E
• Device Catalogue Number: HCS70004
• Device Lot Number: 6462005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention