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

Catalog Number	0010103
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Obstruction/Occlusion (2422)
Date of Event	11/29/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2003 - patient was diagnosed with mid epigastric incisional hernia and left periumbilical ventral hernia thereby underwent open repair with implant of composix kugel mesh (device 1) and kugel patch (device 2).Per op notes, ¿an incision was made in the previous gastric upper midline incision over the bulging area of mid epigastric region.The fascial defect was delineated, and a composix kugel mesh (device 1) was placed below the defect in the peritoneal cavity and secured with sutures.The ventral hernia was identified in the periumbilical region to the left, and an incision was made in the left side of umbilicus region.A kugel patch (device 2) was placed and secured with sutures.¿ (b)(6) 2016 - patient was diagnosed with bowel obstruction thereby underwent open repair with excision of composix kugel mesh (device 1) and kugel patch (device 2).Per op notes, ¿the prior midline incision was incised.The dual mesh and the inferior edge of the mesh was identified.The undersurface of the patch was freed from adhesions and divided in the midline.Omentum was densely adherent to the proximal portion of the patch and dissected free.Multiple rough and pointed edges of the mesh were noted and resected all portions of the mesh.Obstruction was identified in the left upper quadrant and mobilized.Seprafilm was placed and secured with sutures.¿.
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 kugel patch (device 2).An additional supplemental emdr was submitted to represent the composix kugel mesh (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: KUGEL 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 ; 8005566756
• MDR Report Key: 24466399
• Report Number: 1213643-2026-00244
• Device Sequence Number: 18719064
• Product Code: FTL
• UDI-Device Identifier: 00801741016356
• UDI-Public: (01)00801741016356(10)43AND221
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 0010103
• Device Lot Number: 43AND221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/27/2026
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 82 KG