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

Catalog Number	1222530
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Seroma (2069); Obstruction/Occlusion (2422)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 1 month post implant of phasix st using ops, patient was diagnosed with adhesions, obstruction and seroma thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists adhesions and seroma as possible complications.This emdr represents bard/davol phasix st mesh w/ ops (device #2).An additional supplemental emdr was submitted to represent bard/davol 3dmax light (device #1).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
Per information provided: (b)(6) 2016: patient was diagnosed with recurrent right inguinal hernia thereby underwent robotic repair with implant of 3dmax light mesh (device #1).Per operative notes, ¿there was a piece of hernia mesh noted overlaying the underlying vasculature and pelvic floor.This was peeled up and indirect inguinal hernia was noted.The 3dmax light mesh (device #1) was placed in the abdominal cavity around the cord structures." (note: the seen mesh was unknown during this repair).(b)(6) 2019: patient was diagnosed with multiple ventral hernias causing and pain and discomfort thereby underwent open repair with implant of phasix st using ops (device #2).Per operative notes, "there were multiple ventral hernias identified.Some of them had incarcerated contents within them.All the incarcerated contents and adhesions were reduced.A phasix st using ops (device #2) was placed to undersurface of the fascia and sutured." (b)(6) 2019: patient was diagnosed with small bowel obstruction and small bowel adhesions thereby underwent removal of 3dmax light mesh (device #1) and phasix st using ops (device #2).Per operative notes, a small pocket of seroma was noted.Identified a layer of permanent mesh (device #2) in the periumbilical region and that was dissected.The loops of small bowel with interloop adhesions and dense adhesions to the peritoneum, right pelvis at the site of inguinal hernia repair were removed.Several strands or ends of mesh (device #1) that were not fully incorporated and were removed.Attorney alleges that patient had adhesions, bowel obstruction, hernia recurrence, seroma, pain and suffering.

• Brand Name: PHASIX ST MESH W/ OPS
• 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: 21898979
• Report Number: 1213643-2025-090169
• Device Sequence Number: 8174849
• Product Code: OWT
• UDI-Device Identifier: 00801741163241
• UDI-Public: (01)00801741163241
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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 Catalogue Number: 1222530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 04/24/2025
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male