DUODOPA_DUOPA 062943

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 062943 manufactured by Abbvie - Medical Device Center.

Event Text Entries

[186010452] Reference record (b)(4). Catalog number is the international list number which is similar to us list number of 062918. A sample return is expected and a follow up medwatch report will be submitted upon completion of investigation. A bezoar is a known complication of a j-peg tube placement. (b)(4). If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[186010453] On (b)(6) 2018, a patient in (b)(6) underwent placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube. A nurse reported that during a gastroscopy, the patient? S intestinal tube was found to have a bezoar. The intestinal tube was replaced and the patient was not hospitalized.
Patient Sequence No: 1, Text Type: D, B5


[188575639] (b)(4). The click adaptor and j-tube were received at abbvie for examination. The j-tube was received in two segments. The click adaptor was connected to one segment of the j tube. A visual inspection was performed. A bezoar was observed near the bolus end of the j-tube. If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[188575640] Additional information received on 27 mar 2020: sample return evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010757606-2020-00210
MDR Report Key9879502
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2020-03-25
Date of Report2020-02-29
Date Mfgr Received2020-02-29
Device Manufacturer Date2018-01-22
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 Number062943
Lot Number32041278
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBVIE - MEDICAL DEVICE CENTER
Manufacturer Address1675 LAKESIDE DRIVE WAUKEGAN IL 60085 US 60085


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-25

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