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

Catalog Number	0123114
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Fistula (1862); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	03/10/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol composix e/x (device #1) used to treat the patient.No lot number has been provided therefore a review of the manufacturing records is not possible.This emdr represents the bard/davol composix e/x (device #1).An additional emdr was submitted to represent the bard/davol ventrio st (device #2).Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix e/x (device #1) on (b)(6) 2008 and unspecified bard/davol ventrio st (device #2) on (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x (device #1) and the ventrio st (device #2).As reported, 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
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix e/x (device #1) on (b)(6) 2008 and unspecified bard/davol ventrio st (device #2) on (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x (device #1) and the ventrio st (device #2).As reported, 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) 2008 - patient was diagnosed with ventral incisional hernias and small bowel obstruction thereby underwent open repair with implant of composix e/x mesh (device #1).Per operative notes, ¿there was an obstruction from one of the small ventral incisional hernias.Multiple facial defects freed up.A composix e/x mesh (device #1) was then placed and secured using sutures.¿ (b)(6) 2012 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with implant of ventrio st (device #2).Per operative notes, ¿freed all small bowel adhesions from hernia sac and previously placed mesh (device #1).A ventrio st mesh (device #2) was then placed intraabdominally, secured using sutures and tacks.¿ (b)(6) 2014 - patient underwent uneventful ultrasound guided drainage of purulent material out of abscess cavity and provided with antibiotics.(b)(6) 2015 - patient was diagnosed with chronic infected abdominal mesh thereby underwent repair with removal of mesh (device #1 & #2).Per operative notes, ¿deep to the fascia there was a pus cavity containing purulent material.The entire upper bilayer mesh and second mesh (device #1 & #2) were removed which densely adherent to colon and bowel.Two days later during wound check removed the mesh found and had developed enterocutaneous fistula.Between (b)(6) 2015 - patient was diagnosed with enterocutaneous fistula thereby underwent treatment and provided antibiotics.Attorney alleges that the patient had abscess, adhesions, bowel obstructions, fistulae, infection, pain, hernia recurrence and draining sinus tract.
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol composix e/x (device #1) used to treat the patient.No lot number has been provided therefore a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided.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.This supplemental emdr represents the bard/davol composix e/x (device #1).An additional supplemental emdr was submitted to represent the bard/davol ventrio st (device #2).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.; 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: 9298467
• Report Number: 1213643-2019-10847
• Device Sequence Number: 13992747
• Product Code: FTL
• UDI-Device Identifier: 00801741031175
• UDI-Public: (01)00801741031175(17)110628(10)43FQD111
• 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: 2008
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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: 06/28/2011
• Device Catalogue Number: 0123114
• Device Lot Number: 43FQD111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 05/02/2025
• 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: 43 YR
• Patient Sex: Male