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

Catalog Number	0134450
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Insufficient Information (4580)
Date of Event	01/09/2012
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 l/p (device #3).Additional emdrs were submitted to represent the bard flat mesh (device #1) and the bard/davol mesh ¿ ventralex (device #2).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 an unspecified bard mesh (bard flat mesh), bard/davol ventralex and composix l/p, circle on (b)(6) 2011 and/or (b)(6) 2012 and/or (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against all devices.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.
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: 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-jul-2011) is considered to be a best estimate.This supplemental emdr represents the bard/davol mesh ¿ composix l/p (device 1).Additional supplemental emdrs were submitted to represent the bard flat mesh (device 3) and the bard/davol mesh ¿ ventralex (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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard mesh (bard flat mesh), bard/davol ventralex and composix l/p, circle on (b)(6) 2011 and/or (b)(6) 2012 and/or (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against all devices.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) 2011 ¿ patient was diagnosed with pelvic adhesions, periumbilical incisional hernia thereby underwent laparoscopic repair with the implant of composix l/p mesh (device 1).Per op notes, ¿hernia was seen in the periumbilical area which was incisional from a tubal ligation.The composix l/p mesh (device 1) was placed in perineal area and sutured circumferentially around hernia, then tacks were used to secure the mesh in anterior abdominal wall.¿ (b)(6) 2012 ¿ patient was diagnosed with chronic abdominal pain, incarcerated ventral hernia, adhesion thereby underwent laparoscopic lysis of adhesion and open repair with the removal of mesh (device 1) and implant of ventralex mesh (device 2).Per op notes, ¿pelvic adhesions from colon were taken down.The large incarcerated anterior wall ventral hernia which had been repaired previously with mesh was noted.The mesh (device 1) was curled and rolled and scarred up into the hernia sac itself and palpable externally.The mesh (device 1) and clips were removed.A large ventralex mesh (device 2) was placed into the wound and anchored to fascia using suture.¿ (b)(6) 2012 ¿ patient was diagnosed with incarcerated recurrent ventral hernia thereby underwent open repair with the removal of mesh (device 2).Per op notes, ¿the hernia sac was identified.The inferior rectus fascia had retracted, and insufficient anchoring of previous patch was noted.The hernia sac was left insitu and patch (device 2) was removed.¿ (b)(6) 2013 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of bard flat mesh (device 3).Per op notes, ¿the hernia sac was identified.A properitoneal plane was developed in the inferior aspect and connected to peritoneum.A bard flat mesh (device 3) was placed into defect and closed circumferentially using sutures.¿ (b)(6) 2019 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of ventralex patch (device 4).Per op notes, ¿the hernia sac was circumferentially opened at the level of the fascial defect.The omental contents were displaced into abdominal cavity.The previous mesh (device 3) was at inferior portion of defect.A large ventralex patch (device 4) was placed into abdominal cavity with the marlex portion in opposition to intra abdominal wall and tacked.¿.

• 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: 14726885
• Report Number: 1213643-2022-94783
• Device Sequence Number: 2276087
• Product Code: FTL
• UDI-Device Identifier: 00801741031267
• UDI-Public: (01)00801741031267(17)160828(10)HUVG0686
• 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: 2011
• 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): 12/26/2025

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: 08/28/2016
• Device Catalogue Number: 0134450
• Device Lot Number: HUVG0686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2011
• 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: 24 YR
• Patient Sex: Female