Brand Name | CLAMP-ON RAISED TOILET SEAT W/ARMS 9153651324 |
Type of Device | ADAPTOR, HYGIENE |
Manufacturer (Section D) |
LERADO GLOBAL |
no. 26-54b, |
7andar h7 edif. centro com |
macau |
CH |
|
MDR Report Key | 4348507 |
MDR Text Key | 16895562 |
Report Number | 1531186-2014-06507 |
Device Sequence Number | 1 |
Product Code |
ILS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Source Type |
Invalid Data |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
12/17/2014,11/03/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/19/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 1302RTS |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/17/2014 |
Distributor Facility Aware Date | 11/03/2014 |
Device Age | 4 MO |
Date Report to Manufacturer | 12/17/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|