DUODOPA_DUOPA 062945

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 2020-03-27 for DUODOPA_DUOPA 062945 manufactured by Abbvie - Medical Device Center.

Event Text Entries

[186716933] Reference record (b)(4). Catalog number is the international list number which is similar to us list number of 062912. The device involved in the event was not returned; therefore a return sample evaluation was not performed. Gastrointestinal perforation is a labeled known event. If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[186716934] On (b)(6) 2019, patient in (b)(6) underwent procedure for placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube. On (b)(6) 2020, it was reported that, nurse visited the patient for abdominal pain and stoma care was performed. The patient had been visited by a gastroenterologist two months ago and suggested to have tubing replacement. It was recommended for pain to visit an on-call hospital. Additional information received on (b)(6) 2020. It was reported that the patient had stoma site inflammation externally and internally with malodorous discharge. On (b)(6) 2020 the patient underwent gastroscopy, stoma culture and ct of the abdomen. Report indicated that a fistula was found in left transverse colon and from the culture obtained, it was found that there is stool outflow from the stomach. The peg-j tube was removed. According to the surgeon, the bowel was eroded by a hard object and does not know if it was due to the tubings. Additional information indicated that on (b)(6) 2020 surgery was performed on the patient, and a part of the patient's stomach and intestine were removed. The surgery went well. Patient was treated with iv antibiotics flagyl and cefoxitin three times a day. The patient was discharged on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010757606-2020-00219
MDR Report Key9891865
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2020-03-27
Date of Report2020-02-28
Date of Event2020-02-01
Date Mfgr Received2020-03-06
Device Manufacturer Date2016-09-23
Date Added to Maude2020-03-27
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 Received2020-03-27
Catalog Number062945
Lot Number32384386
Device Expiration Date2020-02-29
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. Hospitalization; 2. Required No Informationntervention 2020-03-27

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