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 2019-01-22 for COMBI CHAIR 201911314 manufactured by Handicare Ab.
[133867809]
Wheel detached from the the device leg during patient transfer from bathroom to bed causing the device to tilt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009481053-2019-00002 |
| MDR Report Key | 8269190 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-01-22 |
| Date of Report | 2019-11-01 |
| Date of Event | 2018-12-13 |
| Date Facility Aware | 2019-01-09 |
| Date Mfgr Received | 2019-01-07 |
| Date Added to Maude | 2019-01-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NEGAR KLINGENSTIERNA |
| Manufacturer Street | SWEDEN TORSHAMNSGATAN 35 |
| Manufacturer City | KISTA, |
| Manufacturer G1 | HANDICARE AB |
| Manufacturer Street | SWEDEN TORSHAMNSGATAN 35 |
| Manufacturer City | KISTA, |
| 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 | 2019-01-22 |
| Model Number | 201911314 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANDICARE AB |
| Manufacturer Address | TORSHAMNSGATAN 35 TORSHAMNSGATAN 35 KISTA, 16440 SW 16440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-22 |