MAUDE Adverse Event Report: DRIVE DEVILBISS / STME ACQUISITION LLC THERAPEUTIC MATTRESS GRAVITY 9; MATTRESS, FLOTATION THERAPY, NON-POWERED

Patient Problems Dysphagia/ Odynophagia (1815); Hypersensitivity/Allergic reaction (1907)

Event Date 03/18/2024

Event Type  Injury  

Event Description

I was experiencing a tight throat and difficult swallowing and had to visit urgent care for treatment, due to exposure to chemicals in my prescribed medical mattress.Diagnosed with dysphagia, caused from by being exposed to chemicals in my prescribed drive gravity 9 therapeutic mattress.Doctors prescribed prednisone steroids, and antihistamines, and said remove the mattress from the home.

• Brand Name: THERAPEUTIC MATTRESS GRAVITY 9
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): DRIVE DEVILBISS / STME ACQUISITION LLC
• MDR Report Key: 18959959
• MDR Text Key: 338502131
• Report Number: MW5153046
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/19/2024

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2024
• Patient Sequence Number: 1
• Treatment: ANTIHISTAMINES.; BACLOFEN.; CITALOPRAM. ; ELECTRIC WHEELCHAIR.; FULLY AUTOMATIC MEDICAL BED.; HYDROMORPHONE.; IBUPROFEN. ; PREDNISONE STEROIDS.; QUETIAPINE.; TYLENOL.
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American, White