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

Catalog Number	0123113
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix e/x and allomax on (b)(6) 2010 and/or (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x.Attorney alleges that the patient sustained injuries on (b)(6) 2014 and (b)(6) 2017.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 and allomax on (b)(6) 2010 and/or (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x.Attorney alleges that the patient sustained injuries on (b)(6) 2014 and (b)(6) 2017.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) 2010 - patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with the implant of allomax (device #1).Per operative notes, ¿adhesions of omentum to the anterior abdominal wall were taken down.Then a allomax graft (device #1) was used for repair and secured by tackers.¿ (b)(6) 2011 - the mesh repairs eventually broke down and patient presented with incarcerated ventral hernias, and underwent open exploration and primary sutured repair of hernias.(b)(6) 2012 - patient was diagnosed with incarcerated recurrent ventral hernia, multiple smaller swiss-cheese defects, partial bowel obstruction and pain thereby underwent laparoscopic repair with the implant of composix e/x (device #2).Per operative notes, ¿multiple adhesions to the anterior abdominal wall were taken down.Then a composix e/x mesh (device #2) was used for repair and secured to the anterior abdominal wall.¿ (b)(6) 2014 - patient was diagnosed with multiple recurrent ventral hernia and infection thereby underwent open repair.Per operative notes, ¿all adhesions were taken down.Previously placed composix e/x mesh (device #2) was pulled away from the left edge of the hernia repair and it was re-sutured to the abdominal wall." (b)(6) 2017 - patient was diagnosed with recurrent symptomatic ventral hernia thereby underwent open repair with the removal of composix e/x mesh (device #2).Per operative notes, ¿hernia sac and adhesions were taken down.Then a previously placed composix e/x mesh (device #2) was removed, and a synthetic mesh was used for repair and secured by sutures.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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.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.H11: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.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the date of event.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-sep-2007) 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 blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 11290431
• Report Number: 1213643-2021-00855
• Device Sequence Number: 14585798
• Product Code: FTL
• UDI-Device Identifier: 00801741031168
• UDI-Public: (01)00801741031168(17)121028(10)HURI1036
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: 10/28/2012
• Device Catalogue Number: 0123113
• Device Lot Number: HURI1036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 02/07/2021
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2007
• 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: 52 YR
• Patient Sex: Female