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

Catalog Number	1200008
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient developed a seroma post phasix st mesh implant.Based on the information provided we are unable to determine to what extent, if any, the phasix st mesh may have caused or contributed to the patient's postoperative seroma.As reported, the seroma was drained during follow up and no additional intervention was required.Seroma formation is a known inherent risk of surgery.The contact was unable to provide the product lot number.Without a lot number, a review of the manufacturing batch records could not be conducted.The instructions-for-use (ifu) supplied with the device identifies seroma in the adverse reactions section as a possible post-op complication.Should additional information be provided, a supplemental emdr will be submitted.Not returned - device remains implanted.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study presented with a seroma: on (b)(6) 2019: subject patient underwent robotic-assisted intra-abdominal repair of a primary ventral midline hernia using a circle phasix st mesh 8cm (3 in).The total area of the defect is reported to be 6 cm2.The phasix st mesh was not trimmed and was positioned so that its edges extended beyond the margins of the defect by at least 5cm.Absorbable monofilament suture (quill) was used as the method of perimeter fixation.Absorbable sutures (vicryl) were placed approximately 2cm apart and the fascia was completely reapproximated using a interrupted stitch.Skin closure was attempted with adhesive skin closure.The patient was prescribed with prophylactic antibiotics peri-operatively.There were no infections, fistulas or swiss cheese configurations present at the time of implant.There was a reported presence of a "lump" since surgery.On (b)(6) 2019: the patient had a follow up visit during which the presence of lump was noted and determined to be a seroma.The physician performed an aspiration (5cc).No additional medical or surgical treatment was provided.The ae (adverse event) involving the lump, later identified as a seroma was clinically assessed to be "likely related" to the study device and "likely related" the index procedure, with mild severity.

• Brand Name: PHASIX ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10511358
• Report Number: 1213643-2020-08124
• Device Sequence Number: 11511405
• Product Code: OWT
• UDI-Device Identifier: 00801741095276
• UDI-Public: (01)00801741095276
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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 Catalogue Number: 1200008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/09/2020
• 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: 69 YR