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

Catalog Number	0123680
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Injury (2348); Disability (2371)
Date of Event	07/23/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's 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"; 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.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol 3dmax and composix e/x.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x which was implanted on (b)(6) 2009.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
At this time no conclusions can be made.The patient's 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"; 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.This supplemental emdr represents the bard/davol mesh - composix e/x (device #2).An additional emdr was submitted to represent the bard/davol 3dmax mesh(device #1).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 unspecified bard/davol 3dmax and composix e/x.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x which was implanted on (b)(6) 2009.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) 2004 ¿ patient was diagnosed with ventral in lower quadrants thereby underwent laparoscopic repair with implant of one 3dmax mesh (device #1) and two synthetic mesh.Per operative notes, ¿ in left lower quadrant, hernia was noted around the previously placed mesh.The hernia was reduced and 3dmax mesh (device #1) was placed in left side and sutured.The right lower quadrant hernia was reduced and two synthetic meshes were placed and sutured.¿ (note: the previously placed mesh was unknown) (b)(6) 2009 ¿ patient was diagnosed with incarcerated umbilical hernia with partial bowel obstruction thereby underwent laparoscopic repair with implant of composix e/x mesh (device #2).Per operative notes, ¿incarcerated umbilical hernia with omentum and colon stucked in hernia was noted.Adhesions were reduced and composix e/x mesh (device #2) was placed in the peritoneal cavity and sutured.¿ (b)(6) 2014 - patient was diagnosed with recurrent left inguinal hernia with contracted mesh (device #1) thereby underwent robotic assisted laparoscopic repair with removal of mesh composix e/x (device #1) and partial removal of 3dmax mesh (device #2) and implant of unknown mesh.Per operative notes, ¿ the adhesions from previous meshes (device #1 and #2) were taken down.The mesh (device #2) in epigastrium was completely excised.In left groin, the mesh (device #1) was contracted with hernia.The mesh (device #1) was partially removed and defect was closed with sutures, a synthetic mesh was placed.¿ (note: the mesh implanted in this procedure is unknown).

• Brand Name: MESH - COMPOSIX E/X
• 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: 10151304
• Report Number: 1213643-2020-05760
• Device Sequence Number: 2318727
• Product Code: FTL
• UDI-Device Identifier: 00801741031199
• UDI-Public: (01)00801741031199(10)41DLDP15
• 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: 2009
• 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): 08/04/2025

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 Catalogue Number: 0123680
• Device Lot Number: 41DLDP15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/13/2020
• Supplement Report FDA Received Date: 08/04/2025
• 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: Disability; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female