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

Catalog Number	0123810
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	03/20/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention and "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix e/x on (b)(6) 2006 and ventralight st on (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x.It is alleged that the patient had revision surgery on (b)(6) 2014.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix e/x on (b)(6) 2006 and ventralight st on (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x.It is alleged that the patient had revision surgery on (b)(6) 2014.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2006 - patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with implant of composix e/x (device 1).Per op notes, ¿hernia sac was identified in the infraumbilical region and omentum was reduced.A piece of composix e/x mesh (device 1) was placed into the fascia and sutured.¿ (b)(6) 2013 ¿ patient was diagnosed with symptomatic abdominal scarring thereby underwent revision of scar.Per op notes, ¿the bowel was close to surface and intwined with scar.The border of previously placed mesh (device 1) was encountered.The high degree of scarring around umbilicus was left insitu.On right, scar tissue was transected.¿ (b)(6) 2014 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with excision of composix e/x (device 1) and implant of ventralight st (device 2).Per op notes, ¿previous mesh in the upper midline of abdomen was bulging through the fascia and on all sides, mesh was rolled up and bunched up against the bowel.Adhesions were lysed from the mesh.The old mesh (device 1) was completely excised.Bilateral myocutaneous flaps were created.A ventralight st mesh (device 2) was placed intraperitoneally and secured with sutures.Nonfascia tissue in the midline through which previous mesh protruding was excised.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention and "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: 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: 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 E/X
• 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 ; 4018258495
• MDR Report Key: 10193936
• Report Number: 1213643-2020-06174
• Device Sequence Number: 19418537
• Product Code: FTL
• UDI-Device Identifier: 00801741031212
• UDI-Public: (01)00801741031212(10)43FQD597
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2025

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 Catalogue Number: 0123810
• Device Lot Number: 43FQD597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Disability; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female