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.
[3933236]
Pt fell off commode face first due to the seat not being correctly secured in place. No further details of the incident supplied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005536958-2013-00043 |
| MDR Report Key | 3370312 |
| Report Source | 99 |
| Date Received | 2013-09-11 |
| Date of Report | 2013-09-04 |
| Date of Event | 2013-06-01 |
| 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 | P.O. BOX 70 PIJNACKER 2640AB NL 2640 AB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-11 |