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

Catalog Number	1191025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Event reported per the clinical trial dvl-he-018: the subject patient underwent an open relaparotomy with colectomy concomitant ostomy creation/revision/reversal and fistula takedown procedure on (b)(6) 2023, during which a phasix mesh was trimmed, placed in onlay fashion, and secured in place with absorbable monofilament 3-0 vicryl sutures.A 3 cm overlap in all directions was achieved.The midline fascia was completely closed with slow absorbable monofilament 1-0 pds sutures.The patient was discharged from hospital on (b)(6) 2023.On (b)(6) 2024, the subject patient experienced abdominal pain.It was reported that the patient underwent ct scan and medication (iv hydration, antiemetic, analgesic) was provided.No action was taken to the study device.The patient was discharged with bentyl and zofran.As reported, the reported adverse event (abdominal pain) has been assessed per clinician as possibly related to the study device and possibly related to the procedure and recovered/resolved.The ae has been assessed as mild in severity.The reported ae does not meet the definition of a sae (serious adverse event) and the definition of uade (unanticipated adverse device event).
Additional Manufacturer Narrative
As reported, patient was diagnosed with abdominal pain post implant of phasix mesh which has resolved with the medication provided.The clinician has assessed the patient¿s postoperative course as possibly related to the study device and possibly related to the procedure.Pain 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.Review of manufacturing records was performed and shows the product was manufactured to specification.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.H3 other text : not returned.

• 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: 19277755
• Report Number: 1213643-2024-00246
• Device Sequence Number: 12679857
• Product Code: OOD
• UDI-Device Identifier: 00801741107580
• UDI-Public: (01)00801741107580
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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: 05/28/2024
• Device Catalogue Number: 1191025
• Device Lot Number: HUGT1606
• 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: 04/25/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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: 39 YR
• Patient Sex: Male
• Patient Weight: 76 KG