MAUDE Adverse Event Report: BARD SHANNON LIMITED 3005636544 COMPOSIX MESH E/X; SURGICAL MESH

Catalog Number	0123460
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240); Fibrosis (3167)
Date of Event	02/07/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about 1 month post implant of composix mesh e/x, patient was diagnosed with unspecified infection, hernia recurrence, abscess, adhesions and fibrosis thereby underwent repair with mesh removal.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.The warnings section of the ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-oct-2013) is considered to be a best estimate.This emdr represents composix mesh e/x (device #2).An additional supplemental emdr was submitted to represent composix mesh e/x (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 by patient¿s attorney.(b)(6) 2013 - patient was diagnosed with large ventral hernia thereby underwent open repair with the implant of composix e/x mesh (device #1).Per operative notes, ¿identified the hernia sac and was dissected free.A composix e/x mesh (device #1) was tacked into the abdominal cavity using sutures.¿ (b)(6) 2014 - patient was diagnosed with incisional hernia recurrence thereby underwent open repair with the removal of mesh (device #1) and implant of composix e/x mesh (device #2).Per operative notes, ¿hernia sac was removed.Adhesions of small bowel to the anterior abdomen wall and area of small bowel adhesions to the mesh directly with the mesh incorporation into the serosa of the bowel.This piece of mesh (device #1) was removed and then dissected of the bowel.A composix e/x mesh (device #2) was secured using sutures.¿ (b)(6) 2015 - patient was diagnosed with abdominal wall abscess and infected ventral hernia mesh thereby underwent repair with partial removal of mesh (device #2) and implant of biologic mesh.Per operative notes, ¿the mesh was then identified with the abscess of the purulent fluid.The mesh was then removed (device #2) and removing the previous sutures.A biologic mesh was then placed.¿ (b)(6) 2015 - patient visited to hospital for the follow-up of ventral hernia repair.Exposed the dual-layer mesh and this was trimmed back to the granulation tissue.(b)(6) 2015 - patient was diagnosed with ventral hernia thereby underwent with the implant of graft.(b)(6) 2015 - patient visited hospital for an infected mesh from a previous ventral hernia repair.(b)(6) 2016 - patient was diagnosed with incisional hernia thereby underwent open repair with removal of mesh (device #2) and implant of ventrio st (device #3).Per operative notes, ¿encountered the composix type mesh (device #2) in the supraumbilical portion of his midline.This was excised; there were also multiple sutures in the abdominal wall which were removed.Adhesions had been lysed and the mesh (device #2) had been removed.A ventrio st (device #3) was then tacked into the umbilicus.¿ attorney alleged that the patient had abscess, adhesions, infection, pain, hernia recurrence and emotional injuries.

• Brand Name: COMPOSIX MESH E/X
• 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: 21122245
• Report Number: 1213643-2024-094873
• Device Sequence Number: 7436553
• Product Code: FTL
• UDI-Device Identifier: 00801741031182
• UDI-Public: (01)00801741031182(17)190128(10)HUXJ0155
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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: 01/28/2019
• Device Catalogue Number: 0123460
• Device Lot Number: HUXJ0155
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2013
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 91 KG