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

Catalog Number 062918

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

Patient Problem No Code Available (3191)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the is the similar us list number, the international list number is unknown.(b)(4).The device involved in the event was not returned for evaluation, it was discarded; therefore, a return sample evaluation was not performed.Bezoar 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) 2015, patient was started on duopa therapy.The nurse educator reported that on (b)(6) 2020, the patient had a surgery to place lead for deep brain stimulator.It was reported that during surgery, the patients' j tube was pulled out accidentally while the patient was being turned.On (b)(6) 2020 the j tube was replaced and it was found to have a bezoar at the end.

Event Description

Data corrected in section g4.

Manufacturer Narrative

Reference record (b)(4).H11: data corrected in section g4.

• 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: 10968427
• MDR Text Key: 220207955
• Report Number: 3010757606-2020-00771
• 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: health professional,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062918
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PEG TUBE - MANUFACTURER UNK; PEG TUBE - MANUFACTURER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR