MAUDE Adverse Event Report: BARD SHANNON LIMITED 3005636544 MESH ¿ COMPOSIX L/P; SURGICAL MESH

Catalog Number	0134810
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Necrosis (1971); Fluid Discharge (2686)
Date of Event	09/20/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 11 days post implant of composix l/p, patient was diagnosed with abscess, adhesions, fluid discharge and necrosis.The instructions-for-use supplied with the device list adhesions as a possible complication.Note, the manufacturing date (15-dec-2007) is considered to be a best estimate.This supplemental emdr represents the bard/davol mesh ¿ composix l/p (device #2).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.
Event or Problem Description
Per information provided: (b)(6) 2004 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of composix kugel mesh (device #1).Per operative notes, "the hernia was identified and dissected free down to the level of fascia.The defect was noted and a composix kugel mesh (device #1) was sewn with sutures." (b)(6) 2007 - patient was diagnosed with draining umbilical granulation wound thereby underwent excision of granulation tissue and closure of umbilical hernia.Per operative notes, "the granulation and necrotic tissues were completely excised along with a suture.The fascial edges were adherent to the underlying mesh (device #1)." (b)(6) 2008 - patient was diagnosed with chronically infected hernia mesh thereby underwent open repair with removal of mesh (device #1) and implant of biologic mesh.Per operative notes, "the infected mesh (device #1) was removed completely.A small portion of omentum adherent to the mesh was also excised.A piece of biologic mesh was sutured." (b)(6) 2009 - patient was diagnosed with recurrent incisional hernia (x4) thereby underwent laparoscopic repair with the implant of composix l/p mesh (device #2).Per operative notes, "adhesions noted at the abdominal cavity and multiple hernia defects adjacent to midline was also noted.Two large incarcerated defects were adhered to the loops of small bowel.This was taken down.A composix l/p mesh (device #2) was placed and sutured." (b)(6) 2009 - patient was diagnosed with intra-abdominal abscess thereby underwent drainage of abscess and removal of mesh (device #2).Per operative notes, "the mesh (device #2) was identified with large amount of yellow fluid, the mesh was somewhat adherent to the bowel.The mesh (device #2) was removed completely.Multiple abscesses were found in each quadrant and drained.The necrotic fascia was debrided." (b)(6) 2011 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of synthetic mesh.Attorney alleges that the patient had abscess, adhesions, fistulae, infection, mesh migration, pain, hernia recurrence and emotional injuries.It was also alleged that the patient underwent additional surgeries on (b)(6) 2007 for the excision of granulation tissue, (b)(6) 2009 for recurrent incisional hernias, (b)(6) 2009 for an intra-abdominal abscess, (b)(6) 2009 for debridement of abdominal wall fascia, (b)(6) 2011 for recurrent incisional hernias and (b)(6) 2011 and for an infected abdominal wall hematoma.

• Brand Name: MESH ¿ COMPOSIX L/P
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• 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 ; 4018258495
• MDR Report Key: 21889887
• Report Number: 1213643-2025-090167
• Device Sequence Number: 3434516
• Product Code: FTL
• UDI-Device Identifier: 00801741031311
• UDI-Public: (01)00801741031311(17)130128(10)HURL0244
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: KO61754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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: 01/28/2013
• Device Catalogue Number: 0134810
• Device Lot Number: HURL0244
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2007
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 128 KG