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); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Scar Tissue (2060); Seroma (2069); Hernia (2240); Injury (2348)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol phasix(device #2) may have caused or contributed to the reported event.The attorney alleges that the patient had subsequent surgical intervention; however no details have been provided.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol phasix (device #2).An additional emdr was submitted to represent the bard/davol ventralight st(device #1).Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventralight st (device #1) and phasix (device #2) on (b)(6) 2013 or (b)(6) 2018.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventralight st (device #1) and phasix (device #2).As reported, the attorney alleges patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol phasix(device #2) may have caused or contributed to the reported event.The attorney alleges that the patient had subsequent surgical intervention;however no details have been provided.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol phasix(device #2).An additional emdr was submitted to represent the bard/davol ventralight st(device #1).Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, post implant of phasix mesh, patient was diagnosed with hernia recurrence, seroma and scar tissue thereby underwent revision surgery.The instructions-for-use supplied with the device lists hernia recurrence and seroma as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-oct-2017) is considered to be a best estimate.This supplemental emdr represents phasix mesh (device #2), an additional supplemental emdr was submitted to represent ventralight st mesh (device #1) and additional emdr was submitted to represent bard flat mesh (device #3) note: section a through f - the information provided by bard 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 bard.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol ventralight st(device #1) and phasix(device #2) on (b)(6) 2013 or (b)(6) 2018.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol ventralight st(device #1) and phasix(device #2).As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2013- patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh (device #1).Per operative notes, "the incarcerated omentum was identified within the lower abdominal wall hernia, this was reduced.A ventralight st mesh (device #1) was placed and tacked." (b)(6) 2018- patient was diagnosed with abdominal pain and recurrent ventral hernia thereby underwent laparoscopic converted to open repair with the implant of phasix mesh (device #2).Per operative notes, "adhesions were noted and taken down.The old mesh (device #1) had folded up and migrated.Two hernias were noted converting it into a single hernia.A piece of phasix mesh (device #2) was placed and sutured." (b)(6) 2020- patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of bard flat mesh (device #3).Per operative notes, "the fascial defect was noted in the lowest portion of incision and it was closed using sutures.A piece of bard flat mesh (device #3) was placed over the area and sutured circumferentially." (note: there was no mention/visualization of the previously placed meshes (device #1 and #2) during this procedure) (b)(6) 2020- patient was diagnosed with incarcerated recurrent incisional hernia thereby underwent open repair with explant of mesh (device #3) and implant of phasix mesh (device #4).Per operative notes, "seroma was encountered over the inner most portion of old mesh (device #3).The piece of mesh (device #3) was not incorporated in scar tissue.The entire mesh was removed.The defect and source of hernia was found and excised to the level of fascia.A piece of phasix mesh (device #4) was placed and sutured." attorney alleges that the patient had adhesions, hernia recurrence, mesh migration, pain and suffering, seroma and need for additional surgery.

• 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: 8647563
• Report Number: 1213643-2019-04369
• Device Sequence Number: 1941795
• Product Code: OOD
• UDI-Device Identifier: 00801741077678
• UDI-Public: (01)00801741077678(17)191128(10)HUBX0107
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• 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: 11/28/2019
• Device Catalogue Number: 1190200
• Device Lot Number: HUBX0107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2017
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 127 KG