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

Catalog Number	1190100
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	08/09/2019
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-jul-2017) is considered to be a best estimate.This mdr represents the phasix mesh (device 2).An additional supplemental emdr was submitted to represent the ventralex st mesh (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: on (b)(6) 2016 ¿ patient was diagnosed with ventral hernia thereby underwent open repair with the implant of ventralex st (device 1).Per op notes, ¿laparoscopic appendectomy was done.An umbilical hernia was noted along with another small hernia were coalesced into one defect.A ventralex st mesh (device 1) was placed into abdomen and sutured.¿ on (b)(6) 2018 ¿ patient was diagnosed with incisional hernia; small bowel obstruction thereby underwent open repair with the implant of phasix mesh (device 2).Per op notes, ¿the abdominal hernia was noted.Adhesions were taken down.A phasix mesh (device 2) was placed over the defect using sutures.¿ (note: there is no mention/visualization of device 1 in this procedure.) on (b)(6) 2019 ¿ patient was diagnosed with reducible recurrent incisional hernia thereby underwent open repair with the removal of mesh (device 1, 2) and implant of ventralex st mesh (device 3).Per op notes, ¿the fascial defect was identified.The adhesions were taken down.The previous mesh (device 1 and 2) was removed.A ventralex st mesh (device 3) was placed into the abdominal cavity and secured using sutures.¿.

• 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: 23531412
• Report Number: 1213643-2025-01087
• Device Sequence Number: 9140860
• Product Code: OOD
• UDI-Device Identifier: 00801741077661
• UDI-Public: (01)00801741077661(17)190928(10)HUBU1210
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/06/2025

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: 09/28/2019
• Device Catalogue Number: 1190100
• Device Lot Number: HUBU1210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2017
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 122 KG