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 Bowel Perforation (2668); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/30/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube.On (b)(6) 2022 the patient experienced severe abdominal pain and bloating.The patient underwent a rtg scan which revealed presence of free air in the abdominal cavity.It was reported that the patient experienced a "gastric" perforation during the tubing placement.On (b)(6) 2022 the patient underwent an unspecified abdominal surgical procedure and the tubing was removed and discarded.At the time of report, the patient's condition was poor and the patient started oral / tablet duodopa therapy.It was unclear if the event of gastric perforation referred to the standard procedure for a peg tube placement.

Manufacturer Narrative

Reference record (b)(4).The device involved in the events was discarded; therefore, a return sample evaluation is unable to be performed.Catalog number is the international list number which is similar to us list number of 062910.A pneumoperitoneum and gastro-intestinal perforation are known complication of a peg tube/ j-tube placement.(b)(4).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: 15670976
• MDR Text Key: 302399259
• Report Number: 3010757606-2022-00688
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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: 10/25/2022

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 062941
• Device Lot Number: 32391320
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• 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: ABBVIE J-TUBE, LOT # 32421440.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female