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 |