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 Codes	Hematoma (1884); Wound Infection (2447)
Date of Event	08/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2011 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with the implant of perfix plug (device 1).Per op notes, "incision was made around the umbilical region.A perfix plug and patch (device 1) was placed into the defect using prolene sutures." (b)(6) 2012 - patient had partial small bowel obstruction and abdominal pain.(b)(6) 2017 - patient was diagnosed with enterocutaneous fistula and infected abdominal wall mesh thereby underwent repair with removal of mesh (device 1) and implant of phasix mesh (device 2).Per op notes, "erosion of small bowel to mesh at the umbilicus with enterocutaneous fistula.Loop of bowel stuck up to the backside of it that was fistulized to the mesh and the mesh (device 1) was removed.A phasix mesh (device 2) was placed into the wound." (b)(6) 2017 - patient was diagnosed with abdominal wound infection thereby underwent incision and drainage of abdominal wound.Per op notes, "patient had a hematoma and was evacuated.At the base of the wound was a piece of mesh (device 2) that was sutured to the patient abdomen.".
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-nov-2016) is considered to be a best estimate.This emdr represents the phasix mesh (device 2).An additional supplemental emdr was submitted to represent the bard perfix plug (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.

• 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: 25333464
• Report Number: 1213643-2026-00692
• Device Sequence Number: 9907638
• Product Code: OOD
• UDI-Device Identifier: 00801741077685
• UDI-Public: (01)00801741077685(17)181128(10)HUAY0307
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• 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): 05/27/2026

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: 11/28/2018
• Device Catalogue Number: 1190300
• Device Lot Number: HUAY0307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 93 KG