MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 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	11/08/2018
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 st mesh may have caused or contributed to the patient's postoperative seroma.Seroma formation is a known inherent risk of any surgical procedure.As reported the seroma was drained in postoperative follow up and is noted to be resolved.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 complications.Should additional information be provided, a supplemental emdr will be submitted.Remains implanted.
Event or Problem Description
The following was reported and is associated with phasix st study (b)(6): on (b)(6) 2018: the study patient underwent the repair of an incarcerated hernia near the umbilicus and a second incarcerated hernia located in the epigastrium performed via robotic assisted approach.An 8cm circle phasix st was used in this repair.On (b)(6) 2018: the study patient experienced a post-operative seroma.The seroma was drained during a postoperative follow-up.No further action was taken.On (b)(6) 2018: seroma is noted to have resolved.The seroma was assessed per the clinical pi to be likely related to the study device and likely related to the index procedure.The ae has been assessed as moderate in severity by the clinician.The device remains implanted.

• Brand Name: PHASIX ST 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: 10490662
• Report Number: 1213643-2020-20001
• Device Sequence Number: 14095130
• Product Code: OWT
• UDI-Device Identifier: 00801741095276
• UDI-Public: (01)00801741095276
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2020

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): Initial
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/03/2020
• 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: 39 YR