FDA Adverse Event
Summary report: N
INVACARE SOLACE SPS0080 MATTRESS
MDR report key: 3489761
·
Received November 14, 2013
Report
- Report Number
- 3007008421-2013-00002
- Date Received
- November 14, 2013
- Date of Event
- August 1, 2013
- Report Date
- September 19, 2013
- Manufacturer
- FOAM CRAFT A DIV OF FUTURE FOAM INC.
- Product Code
- IKY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE REPORTED INCIDENT RELATES TO THE MATTRESS IS SUNK IN, NO INJURY IS REPORTED AT THIS TIME. THE MANUFACTURER MAKES THE MATTRESSES TO CUSTOMER SPECS, THE CONSUMER WILL NEED TO CONTACT HIS/HER DEALER/DISTRIBUTOR TO REQUEST INFORMATION ON WHAT MATTRESS TYPE WORKS BEST BASED ON HIS/HER NEED. COMPLAINANT, PHONE NUMBER ISSUED IS INCORRECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592187 | INVACARE SOLACE SPS0080 MATTRESS | SPS0080 | IKY | FOAM CRAFT A DIV OF FUTURE FOAM INC. | SPS0080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |