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

Catalog Number	1190300
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	12/17/2019
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-2018) is considered to be a best estimate.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) 2012 - patient was diagnosed with epigastric and umbilical hernia thereby underwent open repair with the implant of composix kugel mesh (device 1) and ventralex mesh (device 2).Per op notes, "previous incision over the patient's epigastric hernia, a composix kugel mesh (device 1) was placed in the abdominal cavity using prolene sutures.Attention was then turned to the umbilicus where a supraumbilical incision was made, a ventralex mesh (device 2) was placed in the defect using prolene sutures." on (b)(6) 2019 - patient was diagnosed with recurrent incisional umbilical hernia thereby underwent repair with removal of mesh (device 1 and 2) and implant of phasix mesh (device 3).Per op notes, "patient's previous midline incision was extending to the level of the umbilicus.There was a defect present in the fascia as well as meshoma, the prior mesh (device 1) contracted into a mass, this was dissected.There were omental adhesions of the ptfe surface of the mesh, these were taken down.Palpated the area of the umbilicus, there was the previously placed umbilical mesh.This umbilical mesh (device 2) was also dissected out.A phasix mesh (device 3) was placed to the retro rectus area." on (b)(6) 2019 - patient underwent repair of incisional hernia cephalad to previous repair with new mesh.

• 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: 24756703
• Report Number: 1213643-2026-00417
• Device Sequence Number: 9091981
• Product Code: OOD
• UDI-Device Identifier: 00801741077685
• UDI-Public: (01)00801741077685(17)200828(10)HUCU3003
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 08/28/2020
• Device Catalogue Number: 1190300
• Device Lot Number: HUCU3003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2018
• 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: Male