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

Catalog Number	1190200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Purulent Discharge (1812); Drug Resistant Bacterial Infection (4553)
Date of Event	12/12/2014
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-jun-2014) is considered to be a best estimate.This emdr represents the bard/davol phasix mesh (device #2).An additional supplemental emdr was submitted to represent the bard/davol ventrio 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.
Event or Problem Description
Per information provided: (b)(6) 2014 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of ventrio st mesh (device #1).Per operative notes, "the hernia sac was removed.A ventrio st mesh (device #1) was placed and sutured." (b)(6) 2014 - patient was diagnosed with infected mesh and adhesions thereby underwent open repair with the implant of phasix mesh (device #2) and removal of mesh (device #1).Per operative notes, "the mesh (device #1) was removed.A phasix mesh (device #2) was placed in a overlay reinforcement of primary closure and tacked." (b)(6) 2014 - patient was diagnosed with right costal margin abscess thereby underwent drainage of abscess, purulent discharge and removal of mesh (device #2).Per operative notes, "a small fluid collection was encountered, prolene sutures were identified and removed.The phasix mesh was removed." (b)(6) 2016 - patient underwent abdominal scar revision, removal of suture granuloma and closure of wound.

• 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 ; 8005566756
• MDR Report Key: 22160606
• Report Number: 1213643-2025-00435
• Device Sequence Number: 8841842
• Product Code: OOD
• UDI-Device Identifier: 00801741077678
• UDI-Public: (01)00801741077678(17)170328(10)HUYFTP13
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: 03/28/2017
• Device Catalogue Number: 1190200
• Device Lot Number: HUYFTP13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2014
• 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: 46 YR
• Patient Sex: Female