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

Catalog Number	0134610
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Injury (2348)
Date of Event	07/30/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol composix lp (device #2) used to treat the patient.The patient's attorney did allege injuries; 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 lp (device #2).An additional emdr was submitted to represent the bard/davol composix lp (device #1).Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix l/p (device #1 and device #2) on (b)(6) 2013.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 composix l/p (device #1 and device #2).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 lp (device #2) used to treat the patient.The patient's attorney did allege injuries; 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 provided, there is no change to the initial determination, no conclusions can be made.Per medical records review, about 9 months post implant of composix l/p mesh, patient was diagnosed with hernia recurrence, adhesions and material deformation thereby underwent repair with mesh removal.Per operative notes, "the mesh was identified, and it was tented".The instructions-for-use supplied with the device list hernia recurrence and adhesions as a possible complications.Review of manufacturing records confirms product was manufactured to specification.Note, the manufacturing date (15-dec-2009) is considered to be a best estimate.This supplemental emdr represents the bard/davol mesh ¿ composix l/p (device #3).An additional supplemental emdr was submitted to represent the bard/davol mesh ¿ composix l/p (device #1) and an additional emdr was submitted to represent the bard/davol mesh ¿ composix l/p (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/davol composix l/p (device #1 and device #2) on (b)(6)2013.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 composix l/p (device #1 and device #2).As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6)2013 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of two composix l/p mesh (device #1 & #2).Per operative notes, ¿the adhesions were lysed, and the defect was measured.Appropriate size composix l/p mesh (device #1) was placed in the peritoneal cavity and stab wound incisions were made bringing the mesh up the abdominal wall using sutures and tacks.A second mesh, composix l/p mesh (device #2), that was placed in the peritoneal cavity.This mesh was tacked deep to the fascia above the defect superiorly and once this was in place, this mesh was sutured to the old mesh to create one large mesh, and this was done using sutures.¿ (b)(6)2013 - patient was diagnosed with abdominal wall hematoma and recurrent ventral hernia thereby underwent open repair with removal of composix l/p meshes (device #1 & #2).Per operative notes, ¿there was scar tissue, which was excised.There was considerable inflammation at the site of the mesh.There were some adhesions involving omentum.Then there was hematoma and bulging of the abdominal wall with the mesh was in place.The mesh (device #1, #2) was very inflamed, and it was removed completely.The recurrent ventral hernia was then repaired using sutures.¿ (b)(6)2013 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of composix l/p mesh (device #3).Per operative notes, ¿there was considerable scarring in the area and the hernia consisted of hernia sac.The sac was opened.An appropriately sized composix l/p mesh (device #3) was placed beneath the fascia and sutured.¿ (b)(6)2014 - patient was diagnosed with multiple recurrent ventral hernia thereby underwent laparoscopic repair with the removal of composix l/p mesh (device #3) and implant of synthetic mesh.Per operative notes, ¿the mesh was identified, and it was tented.Lysis of adhesion was performed.There was a large fascial defect extending from the xiphoid down to the level of low epigastric area.The mesh (device #3) was excised from the abdominal wall.The large hernia sac was dissected.Then a synthetic mesh was placed by overlapping all edges of the fascial defect and secured using sutures.¿ attorney alleged that the patient had abscess, adhesions, hernia recurrence, seroma, pain and suffering.It was also alleged that patient had an ablation procedures due to abdominal hematoma, anxiety, depression, stress, decreased mobility.

• 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: 8603324
• Report Number: 1213643-2019-03765
• Device Sequence Number: 2350038
• Product Code: FTL
• UDI-Device Identifier: 00801741031281
• UDI-Public: (01)00801741031281(17)150228(10)HUTL1743
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• 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): 03/04/2025

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: 02/28/2015
• Device Catalogue Number: 0134610
• Device Lot Number: HUTL1743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2009
• 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: 48 YR
• Patient Sex: Male