Brand Name | LATORIE |
Type of Device | ABDOMINAL PRESSURE CATHETER 9F |
Manufacturer (Section D) |
LABORIE MEDICAL TECHNOLOGIES CANADA ULC |
6415 northwest dr., unit 11 |
mississauga, on L4V1X 1 |
CA L4V1X1 |
|
Manufacturer (Section G) |
IMAK MEXICANA, S. DE R.L. DE C.V. |
breche e-99 norte edificio 5 |
parque industrial reynosa |
reynose, tamaulipas, c.p. 8878 0 |
MX
88780
|
|
Manufacturer Contact |
gerald
loney
|
6415 northwest dr., unit 11 |
mississauga, on L4V 1-X1
|
CA
L4V 1X1
|
6121170
|
|
MDR Report Key | 4648808 |
MDR Text Key | 5685661 |
Report Number | 9681424-2015-00003 |
Device Sequence Number | 1 |
Product Code |
FEN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
03/19/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/01/2017 |
Device Model Number | RPC-9 |
Device Catalogue Number | RPC-9 |
Device Lot Number | CM14119 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 03/11/2015 |
Initial Date Manufacturer Received |
03/02/2015
|
Initial Date FDA Received | 03/19/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/01/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|