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

Catalog Number	1202530
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	12/31/2018
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-apr-2016) is considered to be a best estimate.This mdr represents the phasix st mesh (device 3).Additional supplemental emdr's were submitted to represent the sepramesh ip (device 1) and for sepramesh ip (device 2).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) 2018¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of sepramesh ip mesh (device 1).Per operative notes, ¿in the midline, through the prior incision, a hernia sac from the surrounding tissues were excised and sepramesh ip (device 1) was placed in an underlay fashion and sutured in place with sutures.The wound was irrigated and fascia was closed with sutures.¿ (b)(6) 2012 ¿ patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with implant of sepramesh ip mesh (device 2).Per operative notes, ¿just superior to the prior incision, a hernia with sac was dissected away completely all the way down to level of anterior fascia and removed.A piece of sepramesh ip (device 2) was placed over the defect and sutured in underlay fashion circumferentially.¿ (b)(6) 2017 - patient was diagnosed with recurrent incisional hernia with small bowel obstruction thereby underwent laparoscopic converted into open repair with removal of prior meshes (device 1 and 2) and implant of phasix st mesh (device 3).Per operative notes, ¿there was incarcerated omental fat with the small hernia in the supraumbilical area.The previously placed meshes (device 1 and 2) were found to have pulled away from the hernia defect and loops of bowel along the inferior edge of the meshes (device 1 and 2) which has also pulled away.The adhesions between the loops of small bowel were lysed.Along the inferior portion of the midline incision, there was a piece of meshes (device 1 and 2) densely adherent creating a point of obstruction.The meshes (device 1 and 2) were dissected off the anterior abdominal wall.The hernia defect in the upper and lower area was closed primarily with sutures and repaired with phasix st mesh (device 3) sutured and tacked circumferentially.¿ (b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair.Per operative notes, ¿the significant adhesions between omentum to anterior abdominal wall and prior mesh (device 3) was lysed.The prior mesh (device 3) was found to be in position but there appears to be recurrent incisional hernia.The hernia was reduced, wound was closed and secured with sutures.¿.

• Brand Name: PHASIX ST 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: 24340582
• Report Number: 1213643-2026-00148
• Device Sequence Number: 13211252
• Product Code: OWT
• UDI-Device Identifier: 00801741095375
• UDI-Public: (01)00801741095375(17)170428(10)HUAR2740
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: 04/28/2017
• Device Catalogue Number: 1202530
• Device Lot Number: HUAR2740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2016
• 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: 53 YR
• Patient Sex: Female