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

Catalog Number	1191530
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device, 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.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided a supplemental mdr 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 experienced seroma post-implant of phasix mesh.On (b)(6) 2021 - the subject patient underwent an open colostomy reversal procedure.A bard/davol phasix mesh trimmed and placed in onlay technique.A 3cm overlap in all directions was achieved.The phasix mesh was secured in place with suture fixation only and the midline fascia was closed by running stitch using non bard/davol 1 pds suture.The skin was fully closed with staples.On (b)(6) 2021 - the subject patient was discharged from the hospital.(b)(6) on 2021 - the subject patient was diagnosed with a seroma.The reported adverse event (ae) has been assessed per the clinician as possibly related to the study device and possibly related to the procedure.The ae has been assessed as mild in severity and is recovering/resolving at this time with no additional medical or surgical intervention required.

• 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: 11990556
• Report Number: 1213643-2021-20147
• Device Sequence Number: 19043900
• Product Code: OOD
• UDI-Device Identifier: 00801741107610
• UDI-Public: (01)00801741107610
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 08/28/2021
• Device Catalogue Number: 1191530
• Device Lot Number: HUDU0528
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/14/2021
• 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: 62 YR
• Patient Weight: 60