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

Catalog Number	1202025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690)
Date of Event	07/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2005 - patient was diagnosed with incisional hernia in the llq at previous colostomy site and midline incisional hernia thereby underwent laparoscopic repair with implant of composix e/x (device 1) and composix mesh (device 2).Per op notes, "all the omentum adherent to the abdominal was taken down.Adhesiolysis was performed.The incisional hernia in the prior colostomy site was noted in the llq was reduced.A composix e/x (device 1) was placed and tacked.Midline incisional hernia was noted and reduced.A composix mesh (device 2) was placed and tacked." on (b)(6) 2017 - patient was diagnosed with recurrent multiple incisional hernia and chronic open abdominal wall wound and mesh infection and abdominal pain thereby underwent open repair with excision of composix e/x (device 1), composix mesh (device 2) and implant of phasix st (device 3).Per op notes, "two wound openings were excised.Two areas of chronic wound infection penetrated down to the mesh (device 1 and 2).Cultures were obtained.Dense adherence between omentum and the underside of the prior meshes (device 1 and 2) were taken down.The infected old meshes (device 1 and 2) with tacks were excised entirely.The incisional hernias were noted and reduced the omentum.A phasix st (device 3) was placed and secured using sutures." on 24-jun-2017- patient had abdominal pain.On (b)(6) 2017 - patient had pain and some serosanguineous drainage from the lower aspect of incision was noted.On (b)(6) 2017 - patient had abdominal pain and shortness of breath for duration thereby underwent ct scan.On (b)(6) 2017 - patient had abdominal wall abscess was drained and wound vac was placed.Patient was restarted with bactrim.
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-mar-2017) is considered to be a best estimate.This emdr represents the phasix st mesh (device 3).Additional supplemental emdrs were submitted to represent the composix e/x mesh (device 1) and composix 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.

• 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: 25551992
• Report Number: 1213643-2026-00771
• Device Sequence Number: 14839585
• Product Code: OWT
• UDI-Device Identifier: 00801741095368
• UDI-Public: (01)00801741095368(17)190328(10)HUBQ1388
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/10/2026

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 Expiration Date: 03/28/2019
• Device Catalogue Number: 1202025
• Device Lot Number: HUBQ1388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2017
• 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: Other; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 79 KG