MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 COMPOSIX MESH 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	Abscess (1690); Fistula (1862); Unspecified Infection (1930); Pain (1994); Injury (2348); Disability (2371); Bowel Perforation (2668)
Date of Event	04/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.No medical records have been provided information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol composix e/x (device #1).An additional emdr was submitted to represent the bard/davol perfix plug (device #2).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) 2005: the patient underwent surgery for implant of an unspecified bard/davol composix e/x( device #1).On (b)(6) 2005: the patient underwent surgery for implant of an unspecified bard/davol perfix plug (device #2).The patent is making a claim for an adverse patient outcome against the composix e/x (device #1) and the perfix plug (device #2).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
Addendum based on additional information provided by patients attorney: at this time no conclusions can be made.It is unknown to what extent the bard/davol composix e/x (device #1) device may have caused or contributed to the events.The information provided alleges as a result of the defective nature of the mesh, the patient underwent subsequent surgeries to remove the mesh due to its deterioration and an infection that caused extreme pain and discomfort.Regarding infection; the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed." a manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided, a supplemental emdr will be submitted.This supplemental emdr represents the bard/davol composix e/x (device #1).An additional supplemental emdr was submitted to represent the bard/davol perfix plug (device #2).
Event or Problem Description
As reported on 09/14/2018: the following was alleged by the patient's attorney: in (b)(6) 2005: the patient underwent surgery for implant of an unspecified bard/davol composix e/x(device #1).In (b)(6) 2005: the patient underwent surgery for implant of an unspecified bard/davol perfix plug(device #2).The patent is making a claim for an adverse patient outcome against the composix e/x(device #1) and the perfix plug(device #2).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 legal complaint: (b)(6) 2005: the patient underwent right inguinal hernia repair with a large meshwork, and repair of a ventral hernia off the anterior abdominal wall with placement of large mesh.A bard/davol composix e/x (device #1) was used for the patient's surgery.A bard/davol perfix plug (device #2) was also used for the patient's surgery.(b)(6) 2016: the patient began to experience extreme pain and discomfort with nausea and vomiting and seizure like symptoms and went to the emergency room.(b)(6) 2016 and (b)(6) 2016: the patient underwent subsequent surgeries to remove the mesh due to its deterioration and an infection that caused extreme pain and discomfort.The patient has experienced and continues to experience abdominal discomfort and all related sequelae.The patient has suffered serious bodily injuries that have resulted in pain and suffering, disability, mental anguish, and medical and nursing care and treatment.The foregoing losses and injuries are either permanent or continuing and the patient will continue to suffer those losses in the future.
Additional Manufacturer Narrative
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.No medical records have been provided.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol composix e/x(device #1).An additional emdr was submitted to represent the bard/davol perfix plug (device #2).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 composix e/x(device #1); additional supplemental emdr's were submitted to represent the bard/davol perfix plug (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
The following was alleged by the patient's attorney: (b)(6) 2005: the patient underwent surgery for implant of an unspecified bard/davol composix e/x(device #1).(b)(6) 2005: the patient underwent surgery for implant of an unspecified bard/davol perfix plug(device #2).The patent is making a claim for an adverse patient outcome against the composix e/x(device #1) and the perfix plug(device #2).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) 2005 - patient was diagnosed with incarcerated ventral hernia and right inguinal hernia thereby underwent open repair with the implant of composix e/x mesh (device #1) for ventral hernia and perfix plug (device #2) for inguinal hernia.Per operative notes, "the bowel was separated from unknown mesh.Lysis of adhesions was performed.Recurrent inguinal hernia was noted and a perfix plug (device #2) was placed and sutured.Colonic adhesions were removed and a composix e/x mesh (device #1) was cut placed in right and left side and tacked." (b)(6) 2016 - patient was diagnosed with infected mesh and enterocutaneous fistula thereby underwent removal of mesh.Per operative notes, "the mesh was removed from side to side.Adhesions were noted and taken down." (b)(6) 2016 - patient underwent abdominal washout.Per operative notes, "the enterocutaneous fistula and intestinal perforation have been healed.The old vicryl mesh with bile leak was excised.A new vicryl mesh with multiple perforation were again spread over the area." (b)(6) 2016 - patient underwent removal of mesh.Per operative notes, "the old synthetic mesh was eroding into the bowel.The mesh was excised." from (b)(6) 2016 - patient underwent revision surgeries related to synthetic mesh.

• Brand Name: COMPOSIX MESH 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: 7879550
• Report Number: 1213643-2018-03132
• Device Sequence Number: 16188509
• Product Code: FTL
• UDI-Device Identifier: 00801741031175
• UDI-Public: (01)00801741031175(17)081128(10)43KND219
• 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: 2005
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2025

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: 11/28/2008
• Device Catalogue Number: 0123114
• Device Lot Number: 43KND219
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 11/05/2018; 05/27/2025
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/26/2018; 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2003
• 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; Life Threatening
• Patient Age: 59 YR
• Patient Sex: Male