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

Catalog Number	0123114
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	12/19/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol composix e/x (device #1).Used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.This mdr represents the bard/davol composix e/x(device #1) implanted on (b)(6) 2013.No allegations has been made to the bard/davol ventrio st implanted on (b)(6) 2016.Should additional information be provided a supplemental emdr will be submitted.The information provided by bard 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 bard.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2013: the patient underwent surgery for implant of an unspecified bard/davol composix e/x(device#1).On (b)(6) 2016, the patient underwent surgery for implant of an unspecified bard/davol ventrio st.The patient is only making a claim for an adverse patient outcome against the composix e/x (device #1).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.¿.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2013: the patient underwent surgery for implant of an unspecified bard/davol composix e/x(device#1).(b)(6) 2016, the patient underwent surgery for implant of an unspecified bard/davol ventrio st.The patient is only making a claim for an adverse patient outcome against the composix e/x (device #1).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) 2013 - patient was diagnosed with large ventral hernia thereby underwent open repair with the implant of composix e/x mesh (device #1).Per operative notes, ¿identified the hernia sac and was dissected free.A composix e/x mesh (device #1) was tacked into the abdominal cavity using sutures.¿ (b)(6) 2014 - patient was diagnosed with incisional hernia recurrence thereby underwent open repair with the removal of mesh (device #1) and implant of composix e/x mesh (device #2).Per operative notes, ¿hernia sac was removed.Adhesions of small bowel to the anterior abdomen wall and area of small bowel adhesions to the mesh directly with the mesh incorporation into the serosa of the bowel.This piece of mesh (device #1) was removed and then dissected of the bowel.A composix e/x mesh (device #2) was secured using sutures.¿ (b)(6) 2015 - patient was diagnosed with abdominal wall abscess and infected ventral hernia mesh thereby underwent repair with partial removal of mesh (device #2) and implant of biologic mesh.Per operative notes, ¿the mesh was then identified with the abscess of the purulent fluid.The mesh was then removed (device #2) and removing the previous sutures.A biologic mesh was then placed.¿ (b)(6) 2015 - patient visited to hospital for the follow-up of ventral hernia repair.Exposed the dual-layer mesh and this was trimmed back to the granulation tissue.(b)(6) 2015 - patient was diagnosed with ventral hernia thereby underwent with the implant of alloderm graft.(b)(6) 2015 - patient visited hospital for an infected mesh from a previous ventral hernia repair.(b)(6) 2016 - patient was diagnosed with incisional henia thereby underwent open repair with removal of mesh (device #2) and implant of ventrio st (device #3).Per operative notes, ¿encountered the composix type mesh (device #2) in the supraumbilical portion of his midline.This was excised; there were also multiple sutures in the abdominal wall which were removed.Adhesions had been lysed and the mesh (device #2) had been removed.A ventrio st (device #3) was then tacked into the umbilicus.¿ attorney alleged that the patient had abscess, adhesions, infection, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol composix e/x (device #1).Used to treat the patient.The patient's attorney did not allege a specific device failure or patient adverse event, and no medical records have been provided.Based on the limited information provided at this time, no conclusions can be made.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.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 4 month post implant of composix mesh e/x, patient was diagnosed with hernia recurrence, adhesion thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence, adhesion as possible complications.Review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-dec-2010) is considered to be a best estimate.This supplemental emdr represents the composix mesh e/x (device #1).An additional emdr was submitted to represent the ventralex st mesh (device #2).Note: section a through f - the information provided by bard 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 bard.

• Brand Name: COMPOSIX MESH E/X
• 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: 7718572
• Report Number: 1213643-2018-02474
• Device Sequence Number: 1107969
• Product Code: FTL
• UDI-Device Identifier: 00801741031175
• UDI-Public: (01)00801741031175(17)160128(10)HUUL1462
• 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: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 01/28/2016
• Device Catalogue Number: 0123114
• Device Lot Number: HUUL1462
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2010
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 91 KG