MAUDE Adverse Event Report: FOAM CRAFT A DIVISION OF FUTURE FOAM INC. INVACARE SOLACE SPS0080 MATTRESS

Model Number SPS0080

Device Problems Device Slipped (1584); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2014

Event Type  No Answer Provided  

Event Description

Per (b)(4), the end-user sleeps in the fetal position and stays in this position majority of the day, end-user daughter is complaining that it appears to be sagging in the middle of the bed.Pt weighs about (b)(6).No injury stated.On (b)(6) 2014, the (b)(4) called to state the end-user is experiencing back pain 7857hf.The end-user may need to contact the mattress dealer to discuss the details of why the mattress is sagging in the middle which may be due to possible (wear/tear/age of mattress etc); all mattresses made and shipped form the manufacturer's location are manufactured to customers specifications, quality inspected and in good condition when shipped out.

• Brand Name: INVACARE SOLACE SPS0080 MATTRESS
• Type of Device: SPS0080
• Manufacturer (Section D): FOAM CRAFT A DIVISION OF FUTURE FOAM INC.; 2441 cypress way; fullerton CA 92831
• Manufacturer Contact: 2441 cypress way; fullerton, CA 92831 ; 7144599971
• MDR Report Key: 4368266
• MDR Text Key: 15911750
• Report Number: 3007008421-2014-00008
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SPS0080
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2014
• Initial Date FDA Received: 11/07/2014
• Patient Sequence Number: 1