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

Catalog Number 062943

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

Patient Problems Inflammation (1932); No Code Available (3191)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog number is the international list number which is similar to us list number of 062918.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.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2018, patient in (b)(6) underwent procedure for placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.It was reported that on (b)(6) 2019, the patient was hospitalized due to persistent abdominal pain and vomiting.A computerized tomography was performed and a small intestine inflammation was diagnosed.The patient was treated with unspecified antibiotic medication.The duopa therapy is temporarily interrupted.

Manufacturer Narrative

Reference record (b)(4).

Event Description

Additional information received.The peg-j tube was replaced on (b)(6) 2019 due to small bowel inflammation.There was a collection of indigestible material in the intestine creating a blockage.The bezoar was removed.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• MDR Report Key: 8601577
• MDR Text Key: 144802676
• Report Number: 3010757606-2019-00311
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 062943
• Device Lot Number: 32344336
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBVIE PEG TUBE - 32064207.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR