MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX MESH; SURGICAL MESH

Catalog Number	1190820
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient developed recurrent incisional hematoma post implant of phasix mesh.The clinician has assessed the patient¿s postoperative course of recurrent incisional hematoma as probably related to the study device with causally related to the procedure.However, based on the information provided, no conclusions can be made.Hematoma is a clinically understood potential complication of surgery and is identified in the adverse reaction section of the instructions-for-use, supplied with the device as a possible complication.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported per clinical trial (b)(4): the subject patient underwent an open colectomy and laparoscopic ileocolic resection procedure on (b)(6) 2024 during which a trimmed phasix mesh was placed in an onlay fashion and sutured using absorbable monofilament 2.0 pds sutures.A 3 cm overlap in all directions was achieved.On (b)(6) 2024, the patient was taken back for incisional hematoma evacuated.The subject patient was discharged on (b)(6) 2024.On (b)(6) 2024, subject patient was diagnosed with swelling due to fluid noted at incision site which was recurrent incisional hematoma requiring drainage and was discharged with drains placed on (b)(6) 2024.The reported adverse event (recurrent incisional hematoma) has been assessed per clinician as probably related to the study device and a causal relationship to the procedure and recovering/resolving.The ae has been assessed as severe in severity.The reported ae does meet the definition of a sae (serious adverse event) and does not meet the definition of uade (unanticipated adverse device event).
Additional Manufacturer Narrative
As reported, patient developed recurrent incisional hematoma post implant of phasix mesh.The clinician has assessed the patient¿s postoperative course of recurrent incisional hematoma as probably related to the study device with causally related to the procedure.However, based on the information provided, no conclusions can be made.Hematoma is a clinically understood potential complication of surgery and is identified in the adverse reaction section of the instructions-for-use, supplied with the device as a possible complication.Addendum: h11: this supplemental mdr is submitted to update the dhr results and to correct the udi.Review of manufacturing records shows product was made to specification.Updated fields: b4, g3, g6, h2, h6, h4, h6, h10, h11 corrected field: d4 (unique identifier (udi)) note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
As reported per clinical trial dvl-he-018: the subject patient underwent an open colectomy and laparoscopic ileocolic resection procedure on (b)(6) 2024 during which a trimmed phasix mesh was placed in an onlay fashion and sutured using absorbable monofilament 2.0 pds sutures.A 3 cm overlap in all directions was achieved.On (b)(6) 2024, the patient was taken back for incisional hematoma evacuated.The subject patient was discharged on (b)(6) 2024.On (b)(6) 2024, subject patient was diagnosed with swelling due to fluid noted at incision site which was recurrent incisional hematoma requiring drainage and was discharged with drains placed on (b)(6) 2024.The reported adverse event (recurrent incisional hematoma) has been assessed per clinician as probably related to the study device and a causal relationship to the procedure and recovering/resolving.The ae has been assessed as severe in severity.The reported ae does meet the definition of a sae (serious adverse event) and does not meet the definition of uade (unanticipated adverse device event).

• Brand Name: PHASIX MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 21112775
• Report Number: 1213643-2024-00610
• Device Sequence Number: 7436760
• Product Code: OOD
• UDI-Device Identifier: 00801741107566
• UDI-Public: (01)00801741107566(11)230615(17)250528(10)HUHT1085
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2025
• Device Catalogue Number: 1190820
• Device Lot Number: HUHT1085
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 96 KG