Brand Name | HOME HEMO COMBI SET FOR CANADA |
Type of Device | HEMODIALYSIS SYSTEM FOR HOME USE |
Manufacturer (Section D) |
ERIKA DE REYNOSA, S.A. DE C.V. |
mike allen #1331 |
parque industrial reynosa |
reynosa 88780 |
MX 88780 |
|
Manufacturer (Section G) |
ERIKA DE REYNOSA, S.A. DE C.V. |
mike allen #1331 |
parque industrial reynosa |
reynosa 88780 |
MX
88780
|
|
Manufacturer Contact |
thomas c.
johnson
|
920 winter st. |
waltham, MA 02451
|
7816999499
|
|
MDR Report Key | 7713582 |
MDR Text Key | 114817175 |
Report Number | 8030665-2018-01116 |
Device Sequence Number | 1 |
Product Code |
ONW
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K070049 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
08/10/2018 |
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 |
Lay User/Patient
|
Device Catalogue Number | 03-2932-6 |
Device Lot Number | 17KR01318 |
Was Device Available for Evaluation? |
No
|
Device Age | MO |
Initial Date Manufacturer Received |
07/05/2018
|
Initial Date FDA Received | 07/24/2018 |
Supplement Dates Manufacturer Received | 08/03/2018
|
Supplement Dates FDA Received | 08/10/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |