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

Catalog Number	0123114
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	03/07/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol composix e/x may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2006: the patient underwent surgery for implant of an unspecified bard/davol composix e/x.(b)(6) 2008:the patient had unspecified injuries and underwent revision surgery.The patient is only making a claim for an adverse patient outcome against the composix e/x.The 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.¿.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2006: the patient underwent surgery for implant of an unspecified bard/davol composix e/x.(b)(6) 2008: the patient had unspecified injuries and underwent revision surgery.The patient is only making a claim for an adverse patient outcome against the composix e/x.The 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.¿ addendum per additional information provided: (b)(6) 2006 - patient was diagnosed with an incisional hernia and intraabdominal adhesions thereby underwent open repair with the implant of composix e/x mesh.Per operative notes, ¿fascia in both lateral directions were cleared, hernia sac was opened and dissected adhesions from anterior abdominal wall to clear bowel and adhesions from anterior abdominal wall, once this was done.A of composix e/x mesh was used for repair and secured with sutures.¿ (b)(6) 2008 - patient was diagnosed with small bowel obstruction thereby underwent open repair with removal of composix e/x mesh.Per operative notes, ¿there was an extensive adhesion between the intraperitoneal placement of a composix e/x mesh, and it was cleared.Mesh appeared to be rolled where the proximal small bowel was still closely adherent and the mesh was trimmed.Attorney alleged that the patient had adhesions, bowel obstruction, mesh migration, mesh shrinkage, nerve damage, pain and emotional injuries.
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol composix e/x may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Addendum: this supplemental emdr is submitted to document additional information provided: based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 1 year 11 months post implant of composix e/x, patient was diagnosed with bowel obstruction, adhesions, pain & scar tissue thereby underwent repair with mesh removal.The instructions-for-use supplied with the device list adhesions as a possible complication.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: COMPOSIX MESH E/X
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 8177428
• Report Number: 1213643-2018-04850
• Device Sequence Number: 11339514
• Product Code: FTL
• UDI-Device Identifier: 00801741031175
• UDI-Public: (01)00801741031175
• 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: 2008
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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: 0123114
• Device Lot Number: 43BOD297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 03/13/2025
• 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: 37 YR
• Patient Sex: Female