Brand Name | DUODOPA_DUOPA |
Type of Device | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
Manufacturer (Section D) |
ABBVIE - MEDICAL DEVICE CENTER |
1675 lakeside drive |
waukegan IL 60085 |
|
Manufacturer (Section G) |
ABBVIE - MEDICAL DEVICE CENTER |
1675 lakeside drive |
|
waukegan IL 60085 |
|
Manufacturer Contact |
terry
ingram
|
1675 lakeside drive |
waukegan, IL 60085
|
8479385350
|
|
MDR Report Key | 15946272 |
MDR Text Key | 305143104 |
Report Number | 3010757606-2022-00803 |
Device Sequence Number | 1 |
Product Code |
KNT
|
Combination Product (y/n) | N |
PMA/PMN Number | K142793 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
12/08/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 11/30/2022 |
Device Catalogue Number | 062941 |
Device Lot Number | 32235109 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/24/2022
|
Initial Date FDA Received | 12/08/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/07/2019 |
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 | J TUBE, UNKNOWN MANUFACTURER |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Prefer Not To Disclose |
Patient Weight | 72 KG |