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

Catalog Number 062910

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

Patient Problem Peritonitis (2252)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

Reference record (b(4).Catalog number in d4 is the international list number which is similar to us list number of 062910.It was unknown if the device involved in the event was discarded or will be returned; therefore, a return sample evaluation is unable to be performed.However, if the device is received, a follow up report will be submitted upon completion of the return sample investigation.Peritonitis is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2024 a patient in france underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube.On (b)(6) 2024, the patient had severe abdominal pain.The patient was diagnosed with peritonitis and hospitalized in the gastroenterology department.On (b)(6) 2024 the 15fr peg tube was removed and the patient began enteral nutrition due to malnutrition.A new stoma site was created and abbvie 20fr peg tube was placed.It was reported that the prior stoma site was leaking and clips were put in to stop the leaks.At the time of report, the patient remained hospitalized.

• 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: 18992074
• MDR Text Key: 338807317
• Report Number: 3010757606-2024-000018
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female