MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-09 for PREVALON AIR TURN AND POSITION SYSTEM 700-050 manufactured by Sage Products Llc.
[19295288]
Report received of a patient fall in a long term care facility. The facility reported that the prevalon air turn and position system was on the patient's bed at the time of the fall. The facility reported that they were unable to determine the cause of the incident as it was an "unwitnessed" fall. However, the facility did not think the "sage blue sheet was the cause of the fall. " after the incident, patient was evaluated by physicians on (b)(67) 2014, a right hip fracture was discovered. Although requested, the facility has declined to provide any additional information.
Patient Sequence No: 1, Text Type: D, B5
[19455517]
The returned device was evaluated. Instructions for use, product drawing, and manufacturing specifications were reviewed for the device and all acceptance criteria were met. Based upon review of the available documentation, including product drawing, and inspection record, there is insufficient evidence to conclude the reported complaint can be attributed to a product defect. Product number 700-050, lot 800098 functioned as intended and no failures were identified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419181-2014-00003 |
| MDR Report Key | 4169572 |
| Report Source | 05,06 |
| Date Received | 2014-10-09 |
| Date of Report | 2014-09-15 |
| Date of Event | 2014-09-13 |
| Date Mfgr Received | 2014-09-15 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2014-10-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | REBECCA PIERCE |
| Manufacturer Street | 3909 THREE OAKS RD. |
| Manufacturer City | CARY IL 60013 |
| Manufacturer Country | US |
| Manufacturer Postal | 60013 |
| Manufacturer Phone | 8003232220 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREVALON AIR TURN AND POSITION SYSTEM |
| Generic Name | MANUAL PATIENT TRANSFER DEVICE |
| Product Code | FMR |
| Date Received | 2014-10-09 |
| Returned To Mfg | 2014-09-16 |
| Model Number | 700-050 |
| Catalog Number | 700-050 |
| Lot Number | 800098 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGE PRODUCTS LLC |
| Manufacturer Address | 3909 THREE OAKS RD. CARY IL 60013 US 60013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-09 |