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

Catalog Number	1190400
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Insufficient Information (4580)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol phasix (device #2).An additional emdr was submitted to represent the bard/davol ventralex (device #1).Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for the implant of unspecified bard/davol ventralex hernia patch on (b)(6) 2011 and phasix mesh on (b)(6) 2015.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for the implant of unspecified bard/davol ventralex hernia patch on (b)(6) 2011 and phasix mesh on (b)(6) 2015.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2011 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of the ventralex mesh (device #1).Per operative notes, ¿a ventralex mesh (device #1) was placed and sutured.¿ (b)(6) 2015 - patient was diagnosed with recurrent incisional hernia, cholelithiasis, multiple abdominal masses thereby underwent open repair with the explant of ventralex mesh (device #1) and implant of phasix mesh (device #2).Per operative notes, ¿old ventralex mesh (device #1) was excised.A phasix mesh (device #2) was placed and sutured.¿ (b)(6) 2017 - patient was diagnosed with abdominal wall mass and recurrent incisional hernia thereby underwent robotic laparoscopic repair with the implant of phasix mesh (device #3).Per operative notes, ¿a phasix mesh (device #3) was placed and sutured.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol phasix (device #2).An additional emdr was submitted to represent the bard/davol ventralex (device #1).Should additional information be provided, a supplemental emdr will be submitted.Addendum: this supplemental emdr is submitted to document additional information provided.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-apr-2014) is considered to be a best estimate.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.H11: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.

• 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
• 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: 12015841
• Report Number: 1213643-2021-04796
• Device Sequence Number: 17302447
• Product Code: OOD
• UDI-Device Identifier: 00801741077692
• UDI-Public: (01)00801741077692(17)170428(10)HUYDTP11
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: 04/28/2017
• Device Catalogue Number: 1190400
• Device Lot Number: HUYDTP11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2014
• 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: 36 YR
• Patient Sex: Female
• Patient Weight: 81 KG