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

Catalog Number	0144680
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	04/25/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol composix l/p (device #3) 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 l/p (device #3).An additional emdr was submitted to represent the bard/davol ventrio (device #1) and bard/davol ventrio (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 two (2) unspecified bard/davol ventrio (device #1) and (device #2) on (b)(6) 2010 and unspecified bard/davol composix l/p (device #3) on (b)(6) 2011.As reported, the patient is making a claim for an adverse patient outcome against the two (2) ventrio (device #1) and (device #2) and the composix l/p (device #3).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.".
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol composix l/p (device #3) used to treat the patient.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.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 1 year 8 months post implant of composix l/p mesh, patient was diagnosed with hernia recurrence and adhesions thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-jun-2011) is considered to be a best estimate.This supplemental emdr represents composix l/p mesh (device #3).An additional supplemental emdr's were submitted to represent ventrio mesh (device #1) and ventrio mesh (device #2).And an additional emdr's were submitted to represent ventralight st meshes (device #4, #5 & #6).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 two (2) unspecified bard/davol ventrio (device #1) and (device #2) on (b)(6) 2010 and unspecified bard/davol composix l/p (device #3) on (b)(6) 2011.As reported, the patient is making a claim for an adverse patient outcome against the two (2) ventrio (device #1) and (device #2) and the composix l/p (device #3).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) 2010 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventrio mesh (device #2).Per operative notes, ¿the scar was excised.The fascia and hernia defect were dissected free.Adhesions were taken down from the anterior abdominal wall.A ventrio mesh (device #1) was placed deep to fascia, but it could not laid flat and continuing to buckle over, was removed.Thus, a ventrio mesh (device #2) was placed and secured to the abdominal wall using tacks.¿ (b)(6) 2011 - patient had abdominal pain and was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant composix l/p using echo ps (device #3).Per operative notes, ¿a midline abdominal wall defect just above the level of the umbilicus was noted.There was some colon adherent to the right lateral edge of the hernia.Adhesions of omentum and colon were taken down.The attachments to the hernia sac and posterior aspect of the anterior abdominal wall were taken down up to the level of the superior edge of the previously placed mesh (device #2).The composix l/p using echo ps (device #3) was positioned against posterior aspect of abdominal wall and secured circumferentially using sorbafix protacker.¿ (b)(6) 2013 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the removal of meshes (device #2, #3) and implant of ventralight st mesh (device #4).Per operative notes, ¿the anterior abdominal wall was dissected where omentum was adherent.Two previously placed pieces of mesh were noted and the recurrent hernia was at the junction of meshes.The old meshes (device #2, #3) were removed the hernia defect was repaired using ventralight st mesh (device #4) and secured to abdominal wall using tacks.¿ (b)(6) 2013 - patient was diagnosed with ventral hernia and two right incisional hernia thereby underwent laparoscopic repair with implant of two ventralight st meshes (device #5, #6).Per operative notes, ¿the adhesions of omentum and colon in the midline were lysed.The herniated contents were reduced.There were 2 defects on the right side.The defect was centrally of partial eventration of mesh (device #4) into previous hernia defect.Two ventralight st mesh (device #5, #6) was positioned at the center of each hernia defect and secured to abdominal wall using absorbable tacks.¿ attorney alleged that the patient had adhesions, pain and hernia recurrence.

• Brand Name: MESH ¿ COMPOSIX L/P
• 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: 9298228
• Report Number: 1213643-2019-10831
• Device Sequence Number: 16771512
• Product Code: FTL
• UDI-Device Identifier: 00801741031359
• UDI-Public: (01)00801741031359(17)120728(10)HUVF1735
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K102766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 04/03/2025

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: 07/28/2012
• Device Catalogue Number: 0144680
• Device Lot Number: HUVF1735
• 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: 03/13/2025
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2011
• 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: 36 YR
• Patient Sex: Female
• Patient Weight: 122 KG