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 Problem Bowel Perforation (2668)

Event Date 02/28/2024

Event Type  Injury  

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 after the placement of 20fr peg tube, the patient experienced a perforation and stoma site leaking.The patient underwent a jejunostomy placement with duodopa therapy during the day and enteral nutrition at night.It was unknown if the 20f peg tube remained or was removed.

Manufacturer Narrative

Reference record: (b)(4).Catalog number in d4 is the international list number which is similar to us list number of 062912.It was unknown if the device involved in the event remained in the patient or was removed and or discarded; 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.Gastric intestinal perforation is a known complication of a peg 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
• 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: 18992145
• MDR Text Key: 338886314
• 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: 062945
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/07/2024
• 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): Other
• Patient Age: 69 YR
• Patient Sex: Female