MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-02-20 for COMBI CHAIR 201904314 manufactured by Handicare Ab.
[139604687]
1st incident: cna was moving individual into shower when wheel fell off. Individual was not hurt and was able to walk to another chair. 2cd incident: cna was in the shower room with patient. Cna was holding on to combi chair when the wheel fell off. The cna and was able to steady the chair so that the patient did not fall out of the chair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009481053-2019-00008 |
| MDR Report Key | 8355195 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-02-20 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-01-21 |
| Date Added to Maude | 2019-02-20 |
| 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 Street | RASHTANSKI PAT 2 |
| Manufacturer City | VELES, VELES 1400 |
| Manufacturer Country | MK |
| Manufacturer Postal | 1400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMBI CHAIR |
| Generic Name | CHAIR WITH CASTERS |
| Product Code | INM |
| Date Received | 2019-02-20 |
| Model Number | 201904314 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE AB |
| Manufacturer Address | SWEDEN TORSHAMNSGATAN 35 KISTA, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-20 |