SOFTFORM PREMIER
Report
- Report Number
- 3007582653-2024-00001
- Event Type
- Injury
- Date Received
- September 27, 2024
- Report Date
- September 27, 2024
- Manufacturer
- INVACARE UK
- Product Code
- FMW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
INVACARE WAS MADE AWARE OF AN EVENT THAT OCCURRED IN GERMANY WITH A 1 YEAR OLD 1486874 SOFTFORM PREMIER MATTRESS. THIS MEDWATCH IS BEING FILED IN AN ABUNDANCE OF CAUTION DUE TO THE IPM1080 AND IXL1080 SOFTFORM PREMIER MATTRESS BEING SOLD IN THE US AND WOULD LIKELY HAVE THE SAME OUTCOME IF THIS EVENT WERE TO OCCUR. INVACARE WAS UNABLE TO FURTHER EVALUATE THE MATTRESS DUE TO THE FACILITY CAN NO LONGER FIND THE MATTRESS. A PICTURE WAS RECEIVED WHICH SHOWED THE WHITE FOAM LAYER ON THE TOP AND SHOULD BE ON THE BOTTOM. THE ATTACHED COVER TO THE MATTRESS WAS REMOVED BY THE FACILITY. IT APPEARS THE MATTRESS WAS NOT BEING USED PROPERLY. THE REPORT ALLEGED ¿SEVERE DAMAGE TO THE SKIN¿ ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION CONCERNING DETAILS OF THE TYPE OF INJURY AND WHAT, IF ANY TREATMENT WAS RECEIVED WITHOUT SUCCESS. SHOULD ANY FURTHER INFORMATION BE RECEIVED A FOLLOW UP WILL BE FILED.
THE END USER PURCHASED THE 1486874 SOFTFORM PREMIER MATTRESS IN (B)(6) 2023, AND THEY NOTICED UNUSUAL PRESSURE POINTS SEVERAL TIMES RECENTLY AND THEY REMOVED THE COVER OF THE MATTRESS. PHOTOS OF THE MATTRESS WITHOUT A COVER WERE PROVIDED AND THE WHITE FOAM LAYER LYING ON THE MATTRESS HAS DISINTEGRATED INTO INDIVIDUAL PIECES. THE END USER SUFFERED SEVERE DAMAGE TO HIS SKIN AS A RESULT OF THE MATTRESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1739762 | SOFTFORM PREMIER | COVER, MATTRESS (MEDICAL PURPOSES) | FMW | INVACARE UK | 1486874 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |