MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-10-10 for CARINA350EM manufactured by Handicare Ab.
| Report Number | 3009481053-2019-00042 |
| MDR Report Key | 9174803 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-10-10 |
| Date of Report | 2019-10-31 |
| Date of Event | 2019-09-29 |
| Date Facility Aware | 2019-09-30 |
| Date Mfgr Received | 2019-09-29 |
| Date Added to Maude | 2019-10-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NEGAR KLINGENSTIERNA |
| Manufacturer Street | TORSHAMNSGATAN 35 |
| Manufacturer City | KISTA, 16440 |
| Manufacturer Country | SW |
| Manufacturer Postal | 16440 |
| Manufacturer G1 | BRAKO D.O.O |
| Manufacturer Street | RASHTANSKI PAT 2 |
| Manufacturer City | VELES, 1400 |
| Manufacturer Country | MK |
| Manufacturer Postal Code | 1400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARINA350EM |
| Generic Name | FLOOR LIFTS |
| Product Code | IKX |
| Date Received | 2019-10-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE AB |
| Manufacturer Address | SWEDEN TORSHAMNSGATAN 35 KISTA, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-10 |