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

Model Number	HP0204E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fever (1858); Tachycardia (2095); Unspecified Tissue Injury (4559); Unintended Radiation Exposure (4565)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the clinical study, following an open reversal of hartmann's procedure for perforated diverticulitis wherein a hemostatic patches were used, the patient had to return to the hospital due to left sided abdominal pain due to collection nearby the spleen tear.It was also noted that the patient had tachycardia and fevers at home.This led to concomitant/additional treatment.Diagnostic and ctap (computed tomography arterial portography) exam were performed which confirmed the small collection anterior aspect (around) a small spleen tear.The patient's blood also showed raised inflammatory markers.The collection was too small for drainage.Thus the patient was able to go home the same day on oral antibiotics and analgesia.The patient has been safety netted for worsening symptoms and is currently recovering.
Additional Manufacturer Narrative
D10 concomitant product: hp0204e, hp0204e 2x4cm veriset hemo patch e x6 (lot#n3e0430y).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VERISET
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BAS
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19949313
• Report Number: 1219930-2024-03690
• Device Sequence Number: 8923745
• Product Code: LMG
• UDI-Device Identifier: 20884521082530
• UDI-Public: 20884521082530
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2025
• Device Model Number: HP0204E
• Device Catalogue Number: HP0204E
• Device Lot Number: N4A2502Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/09/2024
• Date Device Manufactured: 01/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11
• Patient Age: 54 YR
• Patient Sex: Male