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

Catalog Number	1190400
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per the medical records review, about 2 years 8 months post implant of phasix mesh, patient was diagnosed with hernia recurrence.The instructions-for-use supplied with the device list hernia recurrence as a possible complication.This emdr represents the phasix mesh (device #2).An additional supplemental emdr was submitted to represent the ventrio st (device #1).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned.
Event or Problem Description
Per information provided by patient's attorney: on (b)(6) 2013 - patient was diagnosed with incarcerated ventral hernia thereby underwent laparoscopic ¿ open repair with the implant of ventrio st (device #1).Per operative notes, "an oblique incision was made down through the previous mesh and a defect was noted with a large piece of omentum incarcerated within hernia, this was resected along with the sac.The small bowel was reduced into the abdominal cavity.A circular piece of ventrio st mesh (device #1) was placed in the abdominal cavity and tacked to the anterior abdominal wall.Then the old mesh and external oblique was closed." (note, no product identifiers found for the previous mesh) on (b)(6) 2014 - patient visited hospital for abdominal pain and fever.On (b)(6) 2014 - patient was diagnosed with infected mesh with recurrent incisional hernia, sepsis thereby underwent component separation, hernia repair with removal of the mesh (device #1) and implanted with phasix mesh (device #2).Per operative notes, "we were able to identify several layers of mesh as overlay well incorporated into the fascia.On dissection, we were able to identify infected mesh (device #1) and was excised off the fascia and facial defect.The hernia sac was kept intact and a small piece of phasix mesh (device #2) was secured over the defect with tacks.Then wound vac was applied.¿ attorney alleges that the patient had abscess, infection, hernia recurrence, mesh excision, pain and emotional injuries.

• Brand Name: PHASIX MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 18562545
• Report Number: 1213643-2024-090247
• Device Sequence Number: 18173795
• Product Code: OOD
• UDI-Device Identifier: 00801741077692
• UDI-Public: (01)00801741077692
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2024

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: 04/28/2016
• Device Catalogue Number: 1190400
• Device Lot Number: HUYBTP04
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 156 KG