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

Catalog Number	0134810
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	10/31/2012
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.This emdr represents the bard/davol mesh ¿ composix (device #2).An emdr was submitted previously for bard/davol mesh ¿ composix kugel (device #1; mdr number - 1213643-2019-01020 on 21-feb-2019).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 kugel hernia patch and composite mesh (composix) on (b)(6) 2007 and/or (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient sustained injuries on (b)(6) 2010.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.The date of implant for composite mesh will be considered as (b)(6) 2012, since the initial legal claim identified the implant date for the composix kugel hernia patch as (b)(6) 2007.
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.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the brand name, 510(k) and sex 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-nov-2011) is considered to be a best estimate.This supplemental emdr represents the bard/davol mesh ¿ composix l/p (device #2).An supplemental emdr was submitted for bard/davol mesh ¿ composix kugel (device #1).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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix kugel hernia patch and composite mesh (composix) on (b)(6) 2007 and/or (b)(6) 2012.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges that the patient sustained injuries on (b)(6) 2010.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.Note: the date of implant for composite mesh will be considered as (b)(6) 2012, since the initial legal claim identified the implant date for the composix kugel hernia patch as (b)(6) 2007.Addendum per additional information provided: (b)(6) 2007 - patient was diagnosed with ventral hernia thereby underwent open repair with implant of composix kugel (device #1).Per op notes, "a composix kugel (device #1) was placed and sutured." (b)(6) 2010 - patient was diagnosed with recurrent ventral hernia, pain thereby underwent laparoscopic repair.Per op notes, "adhesions were reduced and a primary repair was done." (b)(6) 2011 - patient was diagnosed with recurrent ventral hernia and small bowel obstruction thereby underwent open repair.Per op notes, "two small bowel loops stuck to the underside of the edge of the mesh (device #1) were carefully freed.Adhesions were lysed." (b)(6) 2012 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with implant of composix l/p mesh (device #2).Per op notes, "lysis of adhesions was performed and a composix l/p mesh (device #2) was placed and sutured." (b)(6) 2012 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with explant of meshes (device #1 & #2).Per op notes, "the mesh (device #1 & #2) was excised, and adhesions were taken down.A primary repair was done.".

• Brand Name: MESH - COMPOSIX L/P
• 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: 10391508
• Report Number: 1213643-2020-07285
• Device Sequence Number: 14357380
• Product Code: FTL
• UDI-Device Identifier: 00801741031311
• UDI-Public: (01)00801741031311(17)161128(10)HUVK1207
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 11/28/2016
• Device Catalogue Number: 0134810
• Device Lot Number: HUVK1207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2011
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 134 KG