MAUDE Adverse Event Report: MEDICAL BED

Device Problems Break (1069); Device Emits Odor (1425)

Patient Problems Pain (1994); Respiratory Distress (2045)

Event Date 08/15/2018

Event Type  Injury  

Event Description

Reporter called to report having respiratory distress, a smell coming from her pores and pain to her entire body after using a medical mattress that she purchased.Reporter states that the mattress has a very strong odor, is toxic and that the knee portion of the bed gave out.The caller believes that the mattress is made of toxic materials and should not be sold.

• Brand Name: MEDICAL BED
• Type of Device: MEDICAL BED
• MDR Report Key: 7984726
• MDR Text Key: 124735440
• Report Number: MW5080714
• 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: 10/18/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 68