Brand Name | LIBERTY CYCLER SET, SINGLE CONN./EXT. DL |
Type of Device | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY |
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 | 6534900 |
MDR Text Key | 74163543 |
Report Number | 8030665-2017-00211 |
Device Sequence Number | 1 |
Product Code |
FKX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K043363 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,health professional |
Reporter Occupation |
Patient
|
Type of Report
| Initial,Followup |
Report Date |
05/18/2017 |
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 Expiration Date | 09/30/2019 |
Device Catalogue Number | 050-87216 |
Device Lot Number | 16LR08042 |
Other Device ID Number | 00840861100750 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/17/2017 |
Is the Reporter a Health Professional? |
No
|
Device Age | MO |
Initial Date Manufacturer Received |
04/07/2017
|
Initial Date FDA Received | 05/01/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/18/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/24/2016 |
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 |
Treatment | DELFLEX PD FLUID; LIBERTY CYCLER |
Patient Age | 37 YR |
Patient Weight | 181 |