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 Abscess (1690); Pleural Effusion (2010); Peritonitis (2252)

Event Date 04/03/2021

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.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.Peritonitis is a known complication of a peg tube/ j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

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 (b)(6) 2021, the patient was diagnosed with peritonitis and was hospitalized.The cause of the peritonitis was unknown.

Event Description

Additional information received on 27 apr 2021: in (b)(6) 2021, the patient underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.After the placement, the patient experienced increased abdominal pain and a pleural effusion by contiguity.On (b)(6) 2021, the patient experienced an elevated c-reactive protein level.On (b)(6) 2021, the patient was diagnosed with peritonitis.On (b)(6) 2021, the patient experienced an abscess at the subphrenic hydro arterial level.On (b)(6) 2021, the patient experienced an elevated white blood cell count.At the time of report, the peritonitis was resolving.Per reporting healthcare professional, the peritonitis was caused by the peg/j tube.Causality of the pleural effusion and the abscess at the subphrenic hydro arterial level was not reported.

Manufacturer Narrative

Reference record (b)(4).Pleural effusion and abscess are known complications of a peg/j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• MDR Report Key: 11760223
• MDR Text Key: 248445631
• Report Number: 3010757606-2021-00289
• 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: consumer,foreign,health profe
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• 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
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN J-TUBE, LOT # UNKNOWN; UNKNOWN J-TUBE, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 78 YR