MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for CAREVO BAC1111-01 manufactured by Arjohuntleigh Polska Sp. Z O.o..
[188484092]
Arjo was notified about an event with involvement of carevo shower trolley. It was reported that when the caregiver turned the patient over, the side support opened and the patient fell to the ground. The patient was injured and taken to the emergency room. According to the received information the patient sustained the following injuries - broken femur, swollen nose, swollen forehead. The patient was hospitalized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1419652-2020-00018 |
| MDR Report Key | 9876638 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-14 |
| Date Facility Aware | 2020-03-19 |
| Report Date | 2020-03-25 |
| Date Reported to FDA | 2020-03-25 |
| Date Reported to Mfgr | 2020-03-25 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREVO |
| Generic Name | LIFT, PATIENT, NON-AC-POWERED |
| Product Code | FSA |
| Date Received | 2020-03-25 |
| Model Number | BAC1111-01 |
| Device Availability | Y |
| Device Age | 9 MO |
| 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. Hospitalization; 2. Other | 2020-03-25 |