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

Catalog Number	0123790
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Inflammation (1932); Pain (1994); Injury (2348); Disability (2371); Fibrosis (3167)
Date of Event	03/18/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.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.Not returned.
Event or Problem Description
Per legal complaint: (b)(6) 2012 - patient underwent surgery during which the patient was implanted with an unspecified bard/davol composix e/x (device 1) and ventralight st.The patient is making a claim for an adverse patient outcome against the composix e/x (device 1).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
Per legal complaint: (b)(6) 2012 - patient underwent surgery during which the patient was implanted with an unspecified bard/davol composix e/x (device 1) and ventralight st.The patient is making a claim for an adverse patient outcome against the composix e/x (device 1).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) 2012 - patient was diagnosed with umbilical hernia thereby underwent laparoscopic repair with the implant of composix e/x mesh (device #1) on.Per operative notes, ¿the borders of the hernia sac were measured.Then a composix e/x mesh (device #1) was unrolled and tacked up to the intra-abdominal wall.¿ (b)(6) 2013 - patient was diagnosed with chronic pain thereby underwent open repair with the removal of composix e/x mesh (device #1).Per operative notes, ¿there was omentum adhered to the mesh.There was some inflammatory tissue anterior to the mesh.The composix e/x mesh (device #1) was then removed in its entirety.The synthetic mesh was sutured in place with interrupted suture circumferentially.¿ (b)(6) 2015 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of ventralight st mesh (device #2).Per operative notes, ¿the hernia was identified.Then a ventralight st mesh (device #2) was rolled and placed intraperitoneally and secured to the anterior abdominal wall with the suture passer device.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.Addendum: 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.Note, the manufacturing date (15-jan-2012) is considered to be a best estimate.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. -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 boulevard; warwick, RI 02886 ; 4018258495
• MDR Report Key: 8465831
• Report Number: 1213643-2019-02210
• Device Sequence Number: 10811125
• Product Code: FTL
• UDI-Device Identifier: 00801741031205
• UDI-Public: (01)00801741031205(17)170228(10)HUWA1010
• 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: 2012
• Device Explanted Year: 2013
• 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: 02/28/2017
• Device Catalogue Number: 0123790
• Device Lot Number: HUWA1010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2012
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 81 KG