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	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient developed seroma post phasix st 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.Seroma formation is a known inherent risk of surgery.As reported, the patient deferred medical/surgical intervention at this time and is advised to follow up if the seroma becomes symptomatic.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 - remains implanted.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study presented with a postoperative seroma.The subject patient underwent a primary midline umbilical incisional hernia repair via a robotic assisted procedure using intra-abdominal surgical technique and was implanted with an 8cm (3 in) circle phasix st mesh.A minimum of 5cm overlap was achieved in all directions of the incision site (class i, clean wound).Perimeter fixation of the mesh was achieved by using sutures.The patient was prescribed with prophylactic antibiotics perioperatively.During a follow up visit on (b)(6) 2019, the patient presented with seroma.The seroma was assessed by the clinician to be of moderate severity, "likely related" to the study device and "likely related" to the index procedure.The seroma was indicated to be resolving.The patient deferred medical/surgical intervention at this time and will be scheduled for surgery at a future date.The patient was advised to follow up if the seroma becomes symptomatic.

• 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: 10508037
• Report Number: 1213643-2020-08123
• Device Sequence Number: 14201404
• Product Code: OWT
• UDI-Device Identifier: 00801741095276
• UDI-Public: (01)00801741095276
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 08/25/2020
• 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: 50 YR