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

Catalog Number	1200011
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	04/04/2019
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.This mdr represents the phasix st mesh (device 3).Additional supplemental emdr¿s were submitted to represent the composix kugel mesh (device 1) and bard flat mesh (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) 2004 - patient was diagnosed with recurrent ventral and incisional hernia thereby underwent open repair with implant of composix kugel mesh (device 1).Per op notes, "previous synthetic mesh was excised.A medium composix kugel mesh (device 1) was placed beneath the fascia and peritoneum into the abdomen using sutures." (b)(6) 2006 - patient was diagnosed with recurrent ventral hernia thereby underwent repair.Per op notes, "the previous composix kugel mesh was attached to the abdominal wall." (b)(6) 2009 - patient was diagnosed with right abdominal incisional hernia thereby underwent open repair with the implant of bard flat mesh (device 2).Per op notes, "a bard flat mesh (device 2) was secured underlying the fascia." (b)(6) 2019 - patient was diagnosed with small bowel obstruction thereby underwent repair with removal of mesh (device 1 and 2) and implant of phasix st (device 3), small bowel resection, lysis of adhesions.Per op notes, "patient has a bowel obstruction, adhesions were taken down.Loop of small bowel that was adherent to an old mesh that was curled on itself and took down the small bowel off the mesh.The mesh (device 1 and 2) were removed, a phasix st (device 3) was placed to the abdominal wall using sutures." (b)(6) 2019 - patient was diagnosed with abdominal wall abscess thereby underwent incision and drainage of abdominal wall abscess.Per op notes, "an incision was made in the right mid to lower quadrant and a large abscess cavity was entered.Noted the mesh (device 3) this was left in place and then packed the abdomen.".

• 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: 24378476
• Report Number: 1213643-2026-00169
• Device Sequence Number: 4863074
• Product Code: OWT
• UDI-Device Identifier: 00801741095283
• UDI-Public: (01)00801741095283
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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 Catalogue Number: 1200011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 73 YR
• Patient Sex: Female