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

Catalog Number	1190200
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Necrosis (1971); Hernia (2240)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-may-2016) is considered to be a best estimate.This emdr represents the phasix mesh (device #3).Additional supplemental emdr's were submitted to represent the ventrio st (device #2) and additional emdr's were submitted to represent the phasix mesh (device #1 and device #4).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.
Event or Problem Description
Per plaintiff profile form ((b)(6)): attorney alleges that the patient had abscess, adhesions, mesh migration, mesh shrinkage, pain, hernia recurrence wound vac placed and drain placed.Per information provided: (b)(6) 2015- patient was diagnosed with recurrent epigastric incisional hernia thereby underwent open repair with implant of phasix mesh (device #1), small bowel resection and bilateral component separation.Per operative notes, "a substantial defect was noted and a primary fascial closure was performed.A biologic mesh was placed as in fascial underlay position.A phasix mesh (device #1) was placed in fascial overlay fashion and secured circumferentially." (b)(6) 2016- patient was diagnosed with recurrent incisional hernia and small bowel obstruction thereby underwent open repair with the implant of ventrio st mesh (device #2).Per operative notes, "incision made sharply overlying the fascial defect carried down to the sac and opened.Lysis of adhesions was performed.The defect was noted and a ventrio st mesh (device #2) was placed and sutured.The fascia was reapproximated with suture through the immediate underlay mesh (device #1)." (b)(6) 2016- patient was diagnosed with incisional hernia thereby underwent repair with the implant of phasix mesh (device #3).Per operative notes, "bowel adhesions were noted and lysed.The fascia was reapproximated with suture and the defect was measured and a phasix mesh (device #3) was trimmed and placed as a fascial onlay and secured." (b)(6) 2016- patient was diagnosed with multiple incisional hernia thereby underwent open repair with explant of ventrio st mesh (device #2) and implant of phasix mesh (device #4).Per operative notes, "omental and bowel adhesions were noted and taken down.Additional defect was noted in the umbilicus.The previously placed ventrio st mesh (device #2) was contracted and was completely removed.A phasix mesh (device #4) was tacked and sutured." (b)(6) 2016- patient was diagnosed with abdominal wound infection thereby underwent incision, drainage and wound vac placement.Per operative notes, "purulent necrotic fluid was aspirated and the mesh was in place with some necrotic subcutaneous tissue." (b)(6) 2017- patient was diagnosed with abdominal wall abscess thereby underwent drain placement.

• 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: 21938254
• Report Number: 1213643-2025-090183
• Device Sequence Number: 7893155
• Product Code: OOD
• UDI-Device Identifier: 00801741077678
• UDI-Public: (01)00801741077678(17)180528(10)HUAS0681
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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: 05/28/2018
• Device Catalogue Number: 1190200
• Device Lot Number: HUAS0681
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2016
• 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: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 149 KG