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

Catalog Number 062945

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

Patient Problems Septic Shock (2068); Peritonitis (2252)

Event Date 02/01/2024

Event Type  Death  

Manufacturer Narrative

Reference record (b)(4).The device involved in the event was removed from the patient and discarded, therefore, a return sample evaluation is unable to be performed.Catalog number in d4 is the international list number which is similar to us list number of 062912.Peritonitis and septic shock are known complications of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

Complaint received from a italy by a consumer.On (b)(6) 2022 an 84 year old male underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube and percutaneous endoscopic jejunal tube (j-tube).It was reported that the patient died on (b)(6) 2024 due to septic shock following chemical peritonitis from probable tampering/dislocation of the peg tube caused by the patient unintentionally.The consumer reported that the peritonitis was caused by probable infiltration of gastric material into the abdomen following involuntary tampering with the peg tube in a moment of lack of clarity.An autopsy was not performed.Further information regarding the onset dates of the chemical peritonitis, septic shock, diagnostic imaging, laboratory tests, or treatment and/or medical interventions was unknown.Therefore, with very limited information , abbvie has still decided to conservatively report the events of fatal septic shock following chemical peritonitis.

• 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: 18965460
• MDR Text Key: 338428174
• Report Number: 3010757606-2024-000017
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062945
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• 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
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Male