MAUDE Adverse Event Report: ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 062941

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Aspiration Pneumonitis (4455); Skin Infection (4544)

Event Date 05/09/2022

Event Type  Injury  

Event Description

On an unknown date, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On an unknown date, the patient was hospitalized due to a fever, low blood pressure, and a stoma infection.The stoma was very inflamed and was treated with unknown intravenous (iv) antibiotics.The stoma inflammation subsequently improved.

Manufacturer Narrative

(b)(4).Catalog number is the international list number which is similar to us list number of 062910.The device involved in the event remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Stoma site infection is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Manufacturer Narrative

Reference record 2043349.Additional information added to b5, h6.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On an unknown date, the patient was discharged from the hospital.The patient reported that during the hospitalization, she was diagnosed with aspiration pneumonia and sepsis.It was unknown if the sepsis was related to the stoma site infection.The patient reported that the stoma is still weepy.

• 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: 14473638
• MDR Text Key: 293361029
• Report Number: 3010757606-2022-00344
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142793
• 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,Followup
• Report Date: 07/05/2022

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 Catalogue Number: 062941
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 AND LOT #
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female