MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-09-11 for LINIDO COMBI WIDE 201911314 manufactured by Linido.
[17158038]
The pt was getting up from a seated position using the arm rest of the commode for support. The arm rest broke off and the pt fell to the floor. The facilities maintenance staff inspected the unit and found loose and missing screws/bolts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005536958-2013-00044 |
| MDR Report Key | 3370290 |
| Report Source | 99 |
| Date Received | 2013-09-11 |
| Date of Report | 2013-09-04 |
| Date of Event | 2013-06-28 |
| Date Facility Aware | 2013-08-19 |
| Report Date | 2013-09-04 |
| Date Reported to FDA | 2013-09-04 |
| Date Reported to Mfgr | 2013-08-22 |
| Date Added to Maude | 2013-09-27 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINIDO COMBI WIDE |
| Product Code | INB |
| Date Received | 2013-09-11 |
| Catalog Number | 201911314 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINIDO |
| Manufacturer Address | PO BOX 70 PIJNACKER 2640AB NL 2640 AB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-11 |