Brand Name | PUMP MMT-1714K 630G BLACK MMOL CANADA |
Type of Device | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND |
Manufacturer (Section D) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
ceiba norte ind. park #50 road |
juncos 00777 -386 |
* 00777-3869 |
|
Manufacturer (Section G) |
MEDTRONIC PUERTO RICO OPERATIONS CO. |
ceiba norte ind. park #50 road |
|
juncos 00777 -386 |
*
00777-3869
|
|
Manufacturer Contact |
gerwin
de graaff
|
ceiba norte ind. park #50 road |
juncos 00777--386
|
*
00777-3869
|
8185464805
|
|
MDR Report Key | 9876477 |
MDR Text Key | 184811889 |
Report Number | 3004209178-2020-90116 |
Device Sequence Number | 1 |
Product Code |
OZO
|
UDI-Device Identifier | 00643169782396 |
UDI-Public | (01)00643169782396 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/25/2020 |
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 Model Number | MMT-1714K |
Device Catalogue Number | MMT-1714K |
Device Lot Number | HG2KHRW |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/17/2020 |
Initial Date Manufacturer Received |
03/17/2020 |
Initial Date FDA Received | 03/25/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/26/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |