MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-06-19 for SARA 3000 manufactured by Arjohuntleigh Polska Sp. Z.o.o..
[3471614]
According to the information initially reported by arjohuntleigh representative: "kneepad/support issue causing resident to lose their footing on the foot support. One of the two caregivers tried to support the resident but injured her back. The other caregiver was reported to have moved the sera 3000 to possibly help but this may have been counter productive. " additional information provided: "caregiver injured her back when she lost her balance as she tried to help the resident. Caregiver saw her doctor and was off work, but was not hospitalized. No injury to resident. " ref: #3007420694-2013-00031.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419652-2013-00156 |
| MDR Report Key | 3195687 |
| Report Source | 99 |
| Date Received | 2013-06-19 |
| Date of Report | 2013-05-21 |
| Date of Event | 2013-04-28 |
| Date Facility Aware | 2013-05-21 |
| Report Date | 2013-06-19 |
| Date Reported to FDA | 2013-06-19 |
| Date Reported to Mfgr | 2013-06-19 |
| Date Added to Maude | 2013-07-01 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 50 NORTH GARY AVE., SUITE A |
| Manufacturer City | ROSELLE IL 601721684 |
| Manufacturer Country | US |
| Manufacturer Postal | 601721684 |
| Manufacturer G1 | ARJO, INC. |
| Manufacturer Street | 50 NORTH GARY AVE., SUITE A |
| Manufacturer City | ROSELLE IL 60172168 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60172 1684 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARA 3000 |
| Generic Name | NONE |
| Product Code | FRW |
| Date Received | 2013-06-19 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z.O.O. |
| Manufacturer Address | UL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI PL-62052 PL PL-62052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-19 |