MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 MESH - COMPOSIX L/P; SURGICAL MESH

Catalog Number	0134450
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	09/20/2012
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 composix l/p mesh (device 2).An additional supplemental emdr was submitted to represent the modified kugel patch (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.
Event or Problem Description
Per information provided: (b)(6) 2004 ¿ patient was diagnosed with umbilical hernia thereby underwent open repair with the implant of modified kugel patch (device 1).Per op notes, ¿hernia was noted.A modified kugel patch (device 1) was placed and flattened out against preperitoneal space.The tails sutured down to surrounding fascia.¿ (b)(6) 2007 - patient was diagnosed with recurrent ventral hernia, epigastric hernia thereby underwent laparoscopic repair with the implant of composix l/p mesh (device 2).Per op notes, ¿adhesions were lysed.The original mesh (device 1) was identified, and a defect was noted to one side and second hernia defect was also noted.A round piece of composix l/p mesh (device 2) was placed laterally in left flank and secured using protacks.¿ (b)(6) 2012 ¿ patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with the removal of meshes (device 1, 2).Per op notes, ¿the hernia sac was freed up from the subcutaneous tissues.Adhesions of small bowel were freed up.All the mesh (device 1, 2) and tacks were removed.The fascial layer was identified and a piece of synthetic mesh was placed as underlay type repair using sutures.¿.

• Brand Name: MESH - COMPOSIX L/P
• 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: 24697901
• Report Number: 1213643-2026-00379
• Device Sequence Number: 10176394
• Product Code: FTL
• UDI-Device Identifier: 00801741031267
• UDI-Public: (01)00801741031267
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 03/24/2026

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: 0134450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/26/2026
• 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: 59 YR
• Patient Sex: Male