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 Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 11/01/2020

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.(b)(4).The device involved in the event was not returned; therefore a return sample evaluation is unable to be performed.Stoma site infection and buried bumper syndrome are known complications 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) 2013, patient in ireland underwent procedure for the placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.The report indicated that the patient experienced stoma site discharge and was treated with unknown antibiotics.Additional information indicates that the patient had upper endoscopy on (b)(6) 2020 which showed buried bumper syndrome.Gastroenterology team to arrange urgent ct scan next week and treatment plan to be determined.Peg tube feeding will be continued.

• 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: 10931176
• MDR Text Key: 219126542
• Report Number: 3010757606-2020-00758
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2020

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: 02/29/2020
• Device Catalogue Number: 062945
• Device Lot Number: 32384386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2016
• 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 32381469
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR