SEALANT,POLYMERIZING

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-24 for SEALANT,POLYMERIZING manufactured by Baxter Healthcare Corporation.

Event Text Entries

[182574047] Literature article: akar, e. , arif haberal, m. , & dikis, o. ? Efficacy of surgical tissue glues and supporters for treatment of prolonged air leaks in bullous emphysema?. J coll physicians surg pak 2020; 30(1):57-61. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[182574048] It was reported that seven patients? With radiologically confirmed bullous emphysema, underwent video assisted thoracic surgery for secondary spontaneous pneumothorax in which conseal was used. It was reported the patients underwent a wedge resection with a non-baxter stapler and conseal, used at the suture line. It was reported post-operatively, the patients? Experienced prolonged air leaks. The cause of the air leaks was not reported. Treatment for the event was not reported. At the time of this report, the patient outcomes were not reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2020-00916
MDR Report Key9746154
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-24
Date of Report2020-03-23
Date Mfgr Received2020-03-18
Date Added to Maude2020-02-24
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 Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - HAYWARD
Manufacturer Street2024 W WINTON AVE
Manufacturer CityHAYWARD CA 94545
Manufacturer CountryUS
Manufacturer Postal Code94545
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNI
Generic NameSEALANT,POLYMERIZING
Product CodeNBE
Date Received2020-02-24
Model NumberNA
Catalog NumberASKU
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-24

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