MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-06-19 for MATTRESS COVER FOR MEDICAL PURPOSES TURN-Q PLUS manufactured by Invacare Florida Operations.
[4429773]
Per end user? S family member, the hose is leaking on the left side of the turn-q plus mattress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031452-2014-02251 |
| MDR Report Key | 3884685 |
| Report Source | 08 |
| Date Received | 2014-06-19 |
| Date of Report | 2014-05-20 |
| Date of Event | 2014-02-03 |
| Date Mfgr Received | 2014-05-20 |
| Date Added to Maude | 2014-07-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GREGORY STEVENS |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE FLORIDA OPERATIONS |
| Manufacturer Street | 2101 EAST LAKE MARY BLVD |
| Manufacturer City | SANFORD FL 32773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATTRESS COVER FOR MEDICAL PURPOSES |
| Generic Name | 880.6190 |
| Product Code | FMW |
| Date Received | 2014-06-19 |
| Model Number | TURN-Q PLUS |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE FLORIDA OPERATIONS |
| Manufacturer Address | 2101 EAST LAKE MARY BLVD SANFORD FL 32773 US 32773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-19 |