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 Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Seroma (2069)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, we are unable to determine to what extent, if any, the phasix mesh may have caused or contributed to the patient's postoperative wound dehiscence and seroma.Seroma formation is a known inherent risk of any surgical procedure.As reported, the event is reported to be resolving and no further intervention was required.The instructions-for-use supplied with the device lists seroma and wound dehiscence as possible complications.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in february 2020.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 a wound dehiscence and seroma.On (b)(6) 2020 - the patient underwent onlay placement of a phasix mesh, the mesh was trimmed to 25 cm length and 8 cm width and was fixated using sutures with a 3 cm overlap in all directions.On (b)(6) 2020 - the patient experienced wound dehiscence without mesh being exposed.The adverse event (ae) was assessed by the clinician as mild in severity and no medical or surgical intervention was required.Per the clinician, the ae was possibly related to both the study device and the index procedure.On (b)(6) 2020 ¿ the patient presented with a 2 cm seroma.The adverse event (ae) was assessed by the clinician as mild in severity and no medical or surgical intervention was required.Per the clinician, the ae was definitely related to both the study device and index procedure.The wound dehiscence and seroma are assessed to be recovering/resolving.

• 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: 11250443
• Report Number: 1213643-2021-20011
• Device Sequence Number: 3582953
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: other,study,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2021

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: 11/28/2021
• Device Catalogue Number: 1191530
• Device Lot Number: HUDX2670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/29/2021
• 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: Other
• Patient Age: 54 YR
• Patient Weight: 84