MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN VERISET; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	HP0510E
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred post-operatively following a sleeve gastrectomy.The hemostatic compress was used at the level of the splenic pedicle of the patient.After several days, an abscess formed with an underlying vascular break with inflammation.The patient was transferred in reanimation.The patient expired.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred post-operatively following a sleeve gastrectomy.The hemostatic compress was used at the level of the splenic pedicle of the patient.After several days, an abscess formed with an underlying vascular break with inflammation.The device was not alleged to be the source of the abscess.The patient was transferred in icu.The patient expired.

• Brand Name: VERISET
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): COVIDIEN NORTH HAVEN; 195 mcdermott road; north haven CT
• MDR Report Key: 7203154
• Report Number: 1219930-2018-00411
• Device Sequence Number: 16357157
• Product Code: LMG
• UDI-Device Identifier: 10884521082557
• UDI-Public: 10884521082557
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2018
• Device Model Number: HP0510E
• Device Catalogue Number: HP0510E
• Device Lot Number: N7D0325UX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death