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

Catalog Number	0134113
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	01/05/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2007 - patient was diagnosed with incisional hernia, thereby underwent open repair with implant of ventralex mesh (device 1).Per operative notes, "an incision was made into the upper midline.The hernia sac was dissected out.A large ventralex mesh (device 1) was placed into the abdomen and secured it with sutures." on (b)(6) 2008 - patient was diagnosed with adhesion, recurrent ventral incisional hernia, thereby underwent laparoscopic repair with implant of composix l/p mesh (device 2).Per operative notes, "a midline incision was made into the abdomen.The hernia sac was dissected out.There were dense adhesions present into the abdomen.All adhesions were taken down sharply.A composix l/p mesh (device 2) was placed into the anterior abdominal wall and secured it with sutures." on (b)(6) 2010 - patient was diagnosed with recurrent ventral hernia, adhesion, thereby underwent laparoscopic repair with reinforcement of existing mesh.Per operative notes, "multiple loops of small bowel were adherent to the epigastric area.All adhesions were taken down sharply.The previous defect itself had been adequately covered and reinforced with previously placed dual old mesh (device 2) and secured it 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 emdr represents the composix l/p mesh (device 2).An additional supplemental emdr was submitted to represent the ventralex 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: 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: 25666782
• Report Number: 1213643-2026-00823
• Device Sequence Number: 5764630
• Product Code: FTL
• UDI-Device Identifier: 00801741031243
• UDI-Public: (01)00801741031243(17)130228(10)DARA0023
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 02/28/2013
• Device Catalogue Number: 0134113
• Device Lot Number: DARA0023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/30/2026
• 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: 39 YR
• Patient Sex: Male