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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hematoma (1884); Hernia (2240)
Date of Event	01/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per additional information provided: (b)(6) 2012 ¿ patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with the implant of composix kugel patch (device 1).Per op notes, ¿the previous mesh below the umbilicus was noted.The hernia was recurred above the umbilicus.A piece of composix kugel mesh (device 1) was positioned on inner aspect of abdominal wall with the rough against abdominal wall and smooth edge towards peritoneal cavity using sutures.¿ (b)(6) 2012 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the removal of mesh (device 1) and implant of composix l/p mesh (device 2).Per op notes, ¿a large sac was encountered which contained multiple loops.A wad of old mesh was noted to be free floating and had contracted significantly.The ptfe side was indeed against the omentum and bowel and the polypropylene side was not incorporated itself to any adequate fascia.The mesh (device 1) was removed.There was a small rent in fascia.A large composix l/p mesh (device 2) was placed in cavity and laid down with ptfe side against bowel and omentum and polypropylene side facing abdominal cavity using sutures.¿ (b)(6) 2016 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of synthetic mesh.Per op notes, ¿there were multiple adhesions were taken down.There was a piece of small bowel stuck in one of the hernias which came down with counterpulsation.A synthetic mesh was placed into abdominal cavity to cover both defect using sutures.A small hematoma was noted.¿ (note: the previously placed mesh (device 2) was not seen during this procedure).
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-may-2011) is considered to be a best estimate.This mdr represents the composix l/p mesh (device 2).An additional supplemental emdr was submitted to represent the bard/davol mesh-composix kugel (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: 24066324
• Report Number: 1213643-2026-00026
• Device Sequence Number: 21403130
• Product Code: FTL
• UDI-Device Identifier: 00801741031298
• UDI-Public: (01)00801741031298(17)160528(10)HUVE0830
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: 05/28/2016
• Device Catalogue Number: 0134680
• Device Lot Number: HUVE0830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2011
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 122 KG