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

Catalog Number	1192040
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Seroma (2069)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clinician has assessed the patient¿s postoperative course as being ¿definitely¿ related to the study device, however, based on the information provided, no conclusion can be made.Seroma and wound dehiscence are a known inherent risks of abdominal surgery and are listed in the adverse reaction section of the instructions-for-use (ifu) supplied with the device as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in may, 2020.Should additional information be provided a supplemental mdr will be submitted.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced seroma and small skin dehiscence post-implant of phasix mesh.(b)(6) 2021 - the subject patient underwent an open exploratory laparotomy with a bowel resection, lysis of adhesions and ostomy revision.A bard/davol phasix mesh was trimmed and placed in onlay fashion.Mechanical fixation (non-bard/davol) was used to secure the mesh.The mesh was trimmed and adequate overlap of the defect was achieved.Fascial closure was achieved with non-bard/davol suture, in a running stitch technique.It was reported that prophylactic antibiotic (cefotetan) was administered to the patient peri-operatively.(b)(6) 2021 - the patient was discharged home.(b)(6) 2021 - the subject patient was diagnosed with an approximately 2cm seroma causing small skin dehiscence.As reported, the patient has been instructed to return to clinic in 2 weeks and to pack the wound twice a day with dry gauze, and switch to saline gauze once drainage decreases.The patient had also been instructed to switch to aquacel rope in a week.No additional surgical intervention has been provided at this time.As reported, the reported adverse event has been assessed per clinician as definitely related to the study device and definitely related to the procedure.The outcome of the adverse event is recovering/resolving and the severity is reported to be moderate.

• 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
• MDR Report Key: 11725455
• Report Number: 1213643-2021-20096
• Device Sequence Number: 3998627
• Product Code: OOD
• UDI-Device Identifier: 00801741107634
• UDI-Public: (01)00801741107634
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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: 02/28/2022
• Device Catalogue Number: 1192040
• Device Lot Number: HUEP1966
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/26/2021
• 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: Required Intervention
• Patient Age: 50 YR