MAUDE Adverse Event Report: POLIURETANOS., S.A. DE C.V. DRIVE DEVILBISS HEALTHCARE; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number	15970-4280
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident by the end user (who reported on mw5153046) who reported that the mattress was emitting an odor causing tight throat and difficulty swallowing.The end user went to an urgent care facility for treatment and was diagnosed with dysphagia and was prescribed steroids and antihistamines.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): POLIURETANOS., S.A. DE C.V.; alfredo nobel s/n; toluca, estado de mexico 50200 ; MX 50200
• MDR Report Key: 19234934
• Report Number: 2438477-2024-00020
• Device Sequence Number: 5665854
• Product Code: IKY
• UDI-Device Identifier: 00822383586519
• UDI-Public: 822383586519
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2024
• Report Date (Section F): 05/02/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 15970-4280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/05/2024
• Event Location: Home
• Date Report to Manufacturer: 05/03/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 05/02/2024