MAUDE Adverse Event Report: DRIVE DEVILBISS HEALTHCARE DRIVE THERAPEUTIC GRAVITY 9 MATTRESS; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number 15970-4280

Patient Problems Nausea (1970); Pain (1994); Eye Burn (2523)

Event Date 03/08/2024

Event Type  Injury  

Event Description

I as a medical professional and patient, was prescribed a gravity 9 therapeutic mattress from the drive medical company.Use of the mattress made my eyes burn and water, my throat painfully tight and became nauseous.I couldn't be near the mattress and took some hours for me to recover.The tag on the mattress says that it exposes a person to cancerous chemicals and that it contains di(2-ethylhexyl)phthalate.A mattress that a person sleeps on should not contain harmful and or cancerous chemicals, especially equipment that is used for medical patients.

• Brand Name: DRIVE THERAPEUTIC GRAVITY 9 MATTRESS
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): DRIVE DEVILBISS HEALTHCARE; 99 seaview boulevard; port washington NY 11050
• MDR Report Key: 18902279
• MDR Text Key: 337806773
• Report Number: MW5152817
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2024

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 Operator: Lay User/Patient
• Device Model Number: 15970-4280
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 66 KG