EEA TRIEEA28MT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-12 for EEA TRIEEA28MT manufactured by Us Surgical Puerto Rico.

Event Text Entries

[138581461] (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[138581462] According to the reporter, during a sigmoid colon resection procedure, the device stapler used and fired. However post-operatively, the patient came into the emergency room. They found out that the staple line was disrupted on the anterior side and about 1/3 of the anastomosis was opened on the staple line. They also found out that a large leak was present, but the tissue did not appear ischemic. To resolve the issue the surgeon had to give the patient a colostomy and will need to do a follow-up operation. Due to the problem the patient extends hospital stay for about 3-4 days.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2647580-2019-01322
MDR Report Key8414031
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-03-12
Date of Report2019-03-12
Date of Event2019-02-05
Date Mfgr Received2019-02-18
Date Added to Maude2019-03-12
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 ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1US SURGICAL PUERTO RICO
Manufacturer Street201 SABANETAS INDUSTRIAL PARK
Manufacturer CityPONCE PR 007164401
Manufacturer CountryUS
Manufacturer Postal Code007164401
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEEA
Generic NamePLATE, BASE, SHELLAC
Product CodeEEA
Date Received2019-03-12
Model NumberTRIEEA28MT
Catalog NumberTRIEEA28MT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUS SURGICAL PUERTO RICO
Manufacturer Address201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-03-12

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