DUODOPA_DUOPA 062910

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-25 for DUODOPA_DUOPA 062910 manufactured by Abbvie - Medical Device Center.

Event Text Entries

[186011718] Reference record (b)(4). The device involved in the event was not returned; 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.
Patient Sequence No: 1, Text Type: N, H10


[186011719] On (b)(6) 2017, patient in (b)(6) was started on duopa therapy. Report indicated that the patient has green/yellow discharge, redness and granulation at stoma site. The physician was contacted, swab to be taken and patient was treated with courses of unspecified antibiotic medications for the ongoing problem. It was reported that the possibility of stoma site abscess is looked at.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010757606-2020-00212
MDR Report Key9881800
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2020-03-25
Date of Report2020-03-02
Date of Event2020-03-01
Date Mfgr Received2020-03-02
Device Manufacturer Date2018-01-10
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. TERRY INGRAM
Manufacturer Street1675 LAKESIDE DRIVE
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8479385350
Manufacturer G1ABBVIE - MEDICAL DEVICE CENTER
Manufacturer Street1675 LAKESIDE DRIVE
Manufacturer CityWAUKEGAN IL 60085
Manufacturer CountryUS
Manufacturer Postal Code60085
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDUODOPA_DUOPA
Generic NameTUBES, GASTROINTESTINAL (AND ACCESSORIES)
Product CodeKNT
Date Received2020-03-25
Catalog Number062910
Lot Number32023408
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBVIE - MEDICAL DEVICE CENTER
Manufacturer Address1675 LAKESIDE DRIVE WAUKEGAN IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-25

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