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 Codes	Adhesion(s) (1695); Inflammation (1932); Pain (1994); Hernia (2240)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the additional information received, no conclusions can be made.Per medical records review, about 5 years and 5 months post implant of phasix mesh, patient was diagnosed with hernia, adhesion, inflammation and pain.The instruction of use supplied along with device lists recurrence of hernia, hernia, adhesion, inflammation and pain 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-nov-2016) is considered to be a best estimate.This emdr represent the phasix mesh (device #2).An additional supplemental emdr was submitted to represents the ventralex 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
Initial emdr - per information provided: on (b)(6) 2016 - patient was diagnosed with umbilical hernia thereby underwent open repair with the implant of ventralex st mesh.Per operative notes, ¿tissue protruding through the hernia defect, which were dissected off the surrounding adhesions and pushed back into the peritoneal cavity.A ventralex st mesh (device #1) was placed in the retroperitoneal position using suture.¿ on (b)(6) 2017 - patient was diagnosed with incarcerated recurrent ventral hernia thereby underwent open repair with the implant of phasix mesh (device #2).Per operative notes, ¿the contents of the hernia were identified.Adhesiolysis was performed.The old ventralex st mesh (device #1) was dissected free from the abdominal wall.The recurrent hernia was inferior to the mesh and sac was excised.Myofascial advancement flap was performed.The phasix mesh (device #2) was then attached laterally to the edge of the external oblique using suture.¿ on (b)(6) 2022 - patient had hernia recurrence, adhesion, inflammation and pain thereby underwent mesh revision.(note: there is no information was provided in medical record).

• 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: 21949251
• Report Number: 1213643-2025-090185
• Device Sequence Number: 13025744
• Product Code: OOD
• UDI-Device Identifier: 00801741077692
• UDI-Public: (01)00801741077692(17)181128(10)HUAY1591
• 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: 2017
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: 11/28/2018
• Device Catalogue Number: 1190400
• Device Lot Number: HUAY1591
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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: 39 YR
• Patient Sex: Female