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

Catalog Number 062910

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).The device involved in the event remained implanted in the patient and was not returned for evaluation; therefore a return sample evaluation was not performed.Stoma site infection is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2020, patient underwent procedure for placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.Since then, the patient had pain, redness, and oozing from stoma site.On (b)(6) 2020, patient visited emergency room due to increased pain at the stoma site.In the emergency room, a ct scan was done which was suspicious for intramuscular abscess or possible intramuscular hematoma with secondary infection.The stoma was red and had a thick yellow drainage.Patient was prescribed oral clindamycin 300mg 4 times a day for 7 days.

• 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: 9729962
• MDR Text Key: 186285213
• Report Number: 3010757606-2020-00118
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2023
• Device Catalogue Number: 062910
• Device Lot Number: 32341129
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2019
• 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): Required Intervention
• Patient Age: 59 YR