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

Model Number SPS0080

Device Problem Material Integrity Problem (2978)

Patient Problems Skin Irritation (2076); Tissue Breakdown (2681)

Event Date 06/24/2014

Event Type  No Answer Provided  

Event Description

End-user's daughter states that the end-user constantly slips down in mattress as soon as she sits him up.End-user has some skin breakdown on buttocks, both sides.The mattress end-user may need to contact the mattress dealer.All mattresses made and shipped from 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: 4368285
• MDR Text Key: 18292053
• Report Number: 3007008421-2014-00002
• 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