MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Bard Parastomal Patch; Surgical Mesh

Catalog Number	0118003
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Scar Tissue (2060)
Date of Event	03/12/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6)2011 - patient was diagnosed with ventral hernia and parastomal hernia thereby underwent open repair with the implant of sepramesh ip (device 1) and parastomal patch (device 2).Per op notes, "attention to the incisional ventral hernia, a sepramesh ip (device 1) was placed to the anterior abdominal wall.Then a midline incision was made, the parastomal patch (device 2) was placed around the stoma to cover the hernia defect using tacks." (b)(6)2012 - patient was diagnosed with infected mesh thereby underwent repair with removal of mesh (device 1 and 2) and lysis of adhesions.Per op notes, "a vertical midline incision was made at the prior scar.There was an abscess cavity between the mesh and the linea alba which was drained.Explanted the prior placed sepramesh ip (device 1) from the right and left rectus sheath.Then attention to the second mesh that was placed around the colostomy, and were able to dissect free the mesh (device 2) and explanted around the stoma.Lysis of adhesions was performed.Then a biologic mesh was placed.".
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 emdr represents the parastomal patch (device 2).An additional supplemental emdr was submitted to represent the sepramesh ip (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: Bard Parastomal Patch
• 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 ; +1(800)556-6756
• MDR Report Key: 50476015
• Report Number: 1213643-2026-01127
• Device Sequence Number: 18722908
• Product Code: FTL
• UDI-Device Identifier: 00801741031120
• UDI-Public: (01)00801741031120
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: 0118003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 08/27/2026
• 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 Sex: Male