MAUDE Adverse Event Report: FOAM CRAFT A DIVISION OF FUTURE FOAM INC INVACARE SOLACE SRS2080 MATTRESS

Model Number SRS2080

Device Problems Material Integrity Problem (2978); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2014

Event Type  No Answer Provided  

Event Description

Per customer, the cover is ripping, customer has had for two weeks.The customer may need to contact the mattress dealer to discuss the details of why the mattress is ripping, my also need to return it and ask for a replacement; 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 SRS2080 MATTRESS
• Type of Device: SRS2080
• 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: 4368263
• MDR Text Key: 5114110
• Report Number: 3007008421-2014-00006
• 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: SRS2080
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/21/2014
• Initial Date FDA Received: 11/07/2014
• Patient Sequence Number: 1