Brand Name | SYNCHROMED |
Type of Device | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
Manufacturer (Section D) |
RICE CREEK MFG |
7000 central ave ne |
fridley MN 55432 |
|
Manufacturer (Section G) |
RICE CREEK MFG |
7000 central ave ne |
|
fridley MN 55432 |
|
Manufacturer Contact |
lisa
woodward clark
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635263920
|
|
MDR Report Key | 8186032 |
MDR Text Key | 131060109 |
Report Number | 6000030-2018-00105 |
Device Sequence Number | 1 |
Product Code |
LKK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P860004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/20/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/20/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 8617L18 |
Device Catalogue Number | 8617L18 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 12/19/2018 |
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) |
Required Intervention;
|
Patient Age | 24 YR |
|
|