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 Problem No Code Available (3191)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number 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; therefore, a return sample evaluation is unable to be performed.(b)(4).A pneumoperitoneum is a known complication of a peg tube placement.Per the instructions for use (ifu): to secure the peg tube, the peg tube should be pulled until elastic resistance is felt, keep under tension, secure fixation plate into position using the clip, and remain under moderate tension for 24-72 hours to promote good adherence to the stomach wall to the inner abdominal wall.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2021 a patient in spain underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube.On (b)(6) 2021 the patient developed acute abdominal pain that radiated to the entire abdomen.An abdominal x ray showed a pneumoperitoneum secondary to the new peg.The patient received analgesic iv paracetamol and duodopa continued.Patient manifested dyskinesia in all limbs, possibly caused by the abdominal pain.Duodopa parameters were not modified.Patient was discharged from the hospital on (b)(6) 2021.On (b)(6) 2021 patient presented with the presence of a small peristomal erythema with purulent white fluid discharge, related to the healing of the stoma.Not being able to confirm that it was an infection, patient was treated with topical positon.Patient was informed of the importance of leaving the stoma dry after showering.On (b)(6) 2021 it was reported the patient continues with erythema in the stoma, but with slight improvement compared to the previous week.

• 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: 11256420
• MDR Text Key: 229571672
• Report Number: 3010757606-2021-00065
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 062941
• Device Lot Number: 32235109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• 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): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 60