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

Catalog Number	0123790
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Hematoma (1884); Necrosis (1971); Seroma (2069); Hernia (2240); Injury (2348)
Date of Event	02/28/2007
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol composix e/x (device #2) used to treat the patient.The patient's attorney did allege injuries and subsequent surgery; 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.This emdr represents the bard/davol composix e/x (device #2).An additional emdr was submitted to represent the bard/davol flat mesh (device #1) and bard/davol composix kugel (device #3).Not returned.
Event or Problem Description
Attorney alleges the patient underwent surgery for implant of an unspecified bard/davol bard mesh (device #1) or or an unspecified bard/davol composix e/x (device #2) or an unspecified bard/davol composix kugel hernia patch (device #3) on (b)(6) 2003 or (b)(6) 2004 or (b)(6) 2007.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol bard mesh (device #1), the composix e/x (device #2) and the composix kugel hernia patch (device #3).As reported, the attorney alleges patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol composix e/x (device #2) used to treat the patient.The patient's attorney did allege injuries and subsequent surgery; 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: based on the additional information received, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 8 years 1 months post implant of composix e/x mesh, patient was diagnosed with bacterial infection, hernia recurrence, necrosis, hematoma, abscess, seroma, mesh deformation and adhesions thereby underwent repair with mesh removal.The instructions-for-use supplied with the device list hernia recurrence, hematoma, seroma and adhesions as possible complications.In regard to infection, the warnings section in ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." this supplemental emdr represents the composix mesh e/x (device #2).Additional supplemental emdr's were submitted to represent mesh ¿ composix kugel (device #1) and bard flat mesh (device #3).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 the patient underwent surgery for implant of an unspecified bard/davol bard mesh (device #1) or an unspecified bard/davol composix e/x (device #2) or an unspecified bard/davol composix kugel hernia patch (device #3) on (b)(6) 2003 or (b)(6) 2004 or (b)(6) 2007.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol bard mesh (device #1), the composix e/x (device #2) and the composix kugel hernia patch (device #3).As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2003 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of composix kugel (device #1).Per operative notes, ¿a large incision was made on right side of the abdomen.The hernia sac was identified with incarcerated omentum, both were excised.Two additional hernia defects were identified and excised.A composix kugel hernia patch (device #1) was placed and sutured.¿ (b)(6) 2004 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent laparoscopic repair with implant of composix e/x mesh (device #2).Per operative notes, ¿the hernia defect was identified below the old mesh (device #1), and the mesh looks intact.The omentum and two small bowel loop adherents to the hernia sac and old mesh (device #1), take down all the adhesions away from the small bowel and omentum.The hernia sac below the mesh was dissected and implanted with composix e/x mesh (device #2).¿ (b)(6) 2007 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with partial removal of composix e/x (device #2) with implant of bard flat mesh (device #3).Per operative notes, ¿the hernia sac was identified and opened.Adhesions between omentum and back area were excised.The hernia contents on left side were excised and the hernia defect on right side consists of a folded under piece of mesh (device #2).The edge was excised to remove the tack.A bard flat mesh (device #3) was placed and sutured.¿ (b)(6) 2012 - patient was diagnosed with recurrent ventral incarcerated incisional hernia thereby underwent open repair with removal of infected mesh (device #1, #2, #3) and implant of synthetic mesh.Per operative notes, ¿the chronic abdomen abscess was dissected, the hernia sac was identified and opened.A large amount of incarcerated small and large intestine was identified and dissected.The intrabdominal adhesions were lysed.A synthetic mesh was placed and sutured." attorney alleged that the patient had infection, pain & suffering.

• Brand Name: MESH - COMPOSIX 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: 9364078
• Report Number: 1213643-2019-11451
• Device Sequence Number: 2626671
• Product Code: FTL
• UDI-Device Identifier: 00801741031205
• UDI-Public: (01)00801741031205(10)43BOD310
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• 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): 04/24/2025

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 Catalogue Number: 0123790
• Device Lot Number: 43BOD310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 172 KG