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

Catalog Number	0123114
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Pain (1994); Injury (2348); Disability (2371)
Date of Event	10/26/2015
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 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.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) 2007: the patient underwent surgery for implant of an unspecified bard/davol composix e/x.As reported, the patient is making claim for an adverse patient outcome against the bard/davol composix e/x.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
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 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.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.Updated fields: a2, b2, b3, b4, b5, b7, d3, d4 (product catalog no., udi no, corporate lot no.), d.6b (date of explant), g3, g6, h2, h6, h10.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
The following was alleged by the patient's attorney: on (b)(6) 2007: the patient underwent surgery for implant of an unspecified bard/davol composix e/x.As reported, the patient is making claim for an adverse patient outcome against the bard/davol composix e/x.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 investigation provided: on (b)(6) 2007 - patient was diagnosed with indirect left inguinal hernia thereby underwent open repair with the implant of composix e/x mesh.Per operative notes, ¿left lower quadrant incision was made.Hernia sac was dissected out¿ a perfix plug was placed into left inguinal side and secure it with sutures.¿ on (b)(6) 2015 - patient was diagnosed with fistula, infected mesh, adhesion thereby underwent open repair with explant of composix e/x mesh.Per operative notes, ¿a midline incision was made through subcutaneous tissue.Into the abdominal wall there were extensive adhesions all around fistula.All adhesions were taken down.Fistula was removed.Previously placed composix e/x mesh was partially removed.The defect was closed with sutures.¿ on (b)(6) 2015 - patient was diagnosed with fistula thereby underwent open repair with removal of fistula.On (b)(6) 2016 - patient was diagnosed with fistula, infected mesh, thereby underwent open repair with explant of composix e/x mesh.Per operative notes, ¿a midline incision was made.Entire fistula was removed.Previously placed infected composix e/x mesh was removed.The defect was closed with sutures.¿.

• 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: 7673992
• Report Number: 1213643-2018-02305
• Device Sequence Number: 11108595
• Product Code: FTL
• UDI-Device Identifier: 00801741031175
• UDI-Public: (01)00801741031175(10)43KQD298
• 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: 2007
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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: 0123114
• Device Lot Number: 43KQD298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 10/28/2025
• 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: 70 YR
• Patient Sex: Female