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 | 18298783 |
MDR Text Key | 330112288 |
Report Number | 3010757606-2023-00829 |
Device Sequence Number | 1 |
Product Code |
KNT
|
Combination Product (y/n) | N |
Reporter Country Code | SZ |
PMA/PMN Number | K142816 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
12/10/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/10/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | 062943 |
Device Lot Number | 32162362 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 11/11/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/19/2022 |
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 | ABBVIE PEG TUBE, LOT # UNKNOWN |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 80 YR |
Patient Sex | Female |
Patient Weight | 48 KG |