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 Code	Seroma (2069)
Date of Event	05/10/2021
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 and not related to the index procedure, however, based on the information provided, no conclusion can be made.Seroma is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions-for-use (ifu) supplied with the device as a possible complication.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.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 post-implant of phasix mesh.(b)(6) 2021 - the patient underwent an open hepaticojejunostomy.A bard/davol phasix mesh 20x40cm, was trimmed and placed in onlay fashion.The mesh was trimmed and 3cm overlap was achieved in all directions.The phasix mesh was secured in place with suture fixation only and the midline fascia was closed by running stitch using non bard/davol 2-0 pds suture.The skin was fully closed with suture and surgical glue.A drain was placed during the index procedure, intraperitoneally in the right upper quadrant of the abdomen.(b)(6) 2021 - the drain was removed.(b)(6) 2021 - the subject patient was diagnosed with a seroma.(b)(6) 2021 - the ae has resolved and the subject patient has recovered.The adverse event has been assessed per clinician as definitely related to the study device and not related to the index procedure.No additional surgical intervention has been provided at this time.The adverse event has been assessed as mild severity and not a serious adverse event (sae) or a (unanticipated adverse device effect (uade).

• 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: 12273469
• Report Number: 1213643-2021-20217
• Device Sequence Number: 3531673
• Product Code: OOD
• UDI-Device Identifier: 00801741107634
• UDI-Public: (01)00801741107634
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: health professional,other,stu
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

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: 07/20/2021
• Initial Report FDA Received Date: 08/04/2021
• 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: 73 YR
• Patient Weight: 90