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U.S. Department of Health and Human Services

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

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ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Catalog Number 062941
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 07/23/2020
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. The device involved in the event was not returned and the device disposition is unknown; therefore, a return sample evaluation is unable to be 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 an unknown date, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube. On (b)(6) 2020, the patient experienced brown exudate around the stoma. The patient was treated with unknown oral antibiotic. On (b)(6) 2020, it was reported that the stoma site infection with exudate has resolved.

 
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Brand NameDUODOPA_DUOPA
Type of DeviceTUBES, 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 Key10475100
MDR Text Key205089825
Report Number3010757606-2020-00558
Device Sequence Number1
Product Code KNT
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK142793
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 08/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device Catalogue Number062941
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/31/2020 Patient Sequence Number: 1
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