MAUDE Adverse Event Report: CASPER CASPER (BED) MATTRESS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Fainting (1847); Headache (1880); Tinnitus (2103); Tingling (2171); Numbness (2415)

Event Date 05/26/2017

Event Type  Injury  

Event Description

We purchased a mail-order casper bed which is the first bed that made my back ache go away.However, it makes my ears ring, my head either light-headed or pound, my arms and legs tingle and go asleep, and my husband had a stroke after we had it for about 6 months.I truly believe there is some connection, as i do not have any of these things when i sleep anywhere in the house.Frequency: at bedtime.How was it taken or used: sleep on it.Did the problem stop after the person used the dose or stopped taking or using the product: yes.Did the problem return if the person started taking or using the product again: yes.Do you still have the product in case we need to evaluate it: yes.Why was the person using the product: to sleep on.

• Brand Name: CASPER (BED) MATTRESS
• Type of Device: CASPER (BED) MATTRESS
• Manufacturer (Section D): CASPER
• MDR Report Key: 6666701
• MDR Text Key: 78391525
• Report Number: MW5070615
• Device Sequence Number: 1
• Product Code: IKY
• 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: 06/24/2017

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 59