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

Catalog Number	0134680
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	06/24/2009
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.Note, the manufacturing date (15-oct-2008) is considered to be a best estimate.This mdr represents the composix l/p mesh (device 1).An additional supplemental emdr was submitted to represent the composix kugel 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.
Event or Problem Description
Per information provided: (b)(6) 2009 - patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with implant of composix l/p (device 1).Per op notes, ¿incision was made on left side of abdomen.Dense adhesions were noted and lysed.The hernia sac with incarcerated omentum was reduced.A composix l/p (device 1) was placed and secured using sutures.¿ (b)(6) 2009 - patient was diagnosed with recurrent incisional hernia at laparoscopic site thereby underwent open repair with implant of composix kugel (device 2).Per op notes, ¿a large piece of prior mesh (device 1) was noted.This revealed the herniated knuckle of omentum and colon was noted and the omentum and colon were reduced.A composix kugel (device 2) was placed in the peritoneal cavity and tacked.¿ (b)(6) 2010 - patient was diagnosed with recurrent incisional hernia llq thereby underwent open repair mesh revision.Per op notes, ¿the old scar in llq was excised.There was noted to be the old mesh (device 1 and 2) lateral to this new hernia defect with incarcerated omentum and peritoneal fat were reduced.The lateral edge of the old mesh (device 1 and 2) had pulled free from the fascia.A composix l/p (device 3) was placed in the abdominal wall and sutured.The medial edge of the mesh (device 3) was anchored to the old mesh (device 1 and 2) in the abdominal wall using tacks.¿.

• 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: 24001823
• Report Number: 1213643-2026-00005
• Device Sequence Number: 16086054
• Product Code: FTL
• UDI-Device Identifier: 00801741031298
• UDI-Public: (01)00801741031298(17)131028(10)HUSJ0051
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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: 10/28/2013
• Device Catalogue Number: 0134680
• Device Lot Number: HUSJ0051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2008
• 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: 68 YR
• Patient Sex: Female