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

Catalog Number	0123790
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Fistula (1862); Pain (1994); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	07/29/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol composix e/x (device #2) may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.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.This emdr represents the bard/davol composix e/x (device #2) additional mdrs will be submitted to for each of the other bard/davol devices with claims alleged.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol flat mesh (device #1) on (b)(6) 2006, and an unspecified bard/davol composix e/x (device #2 and device #3) on (b)(6) 2007 and on (b)(6) 2008.As reported, the patient is making a claim for an adverse patient outcome against the flat mesh(device #1) and the two (2) composix e/x (devices #2 and #3).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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol flat mesh (device #1) on (b)(6) 2006, and an unspecified bard/davol composix e/x (device #2 and device #3) on (b)(6) 2007 and on (b)(6) 2008.As reported, the patient is making a claim for an adverse patient outcome against the flat mesh(device #1) and the two (2) composix e/x (devices #2 and #3).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 information provided: (b)(6) 2006 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of bard mesh (device #1).Per operative notes, ¿hernia sac was excised to the edge of the rectus fashion.Had a smaller hernia above the main one and they were repair using sutures.A bard mesh (device #1) was then placed on top of this and secured.¿ (b)(6) 2007 - patient had two incisional hernias at lateral umbilicus and superior umbilicus thereby underwent open repair with implant of composix e/x mesh (device #2).Per operative notes, ¿hernia sacs was repaired using a dual lumen composix e/x mesh (device #2) and tacked circumferentially.¿ (b)(6) 2008 - patient was diagnosed with incisional and ventral hernia thereby underwent laparoscopic repair with composix e/x mesh (device #3).Per operative notes, ¿there was an incisional hernia at the most upper aspect of incision and there was another ventral hernia.The upper lip of the previously placed mesh (device #2) pulled through all tacks which still visible on other side of hernia defect.The adhesions were lysed.A composix e/x mesh (device #3) was placed with lower half of the mesh lying underneath the previously placed mesh (device #2) and secured using sutures and tacks.¿ (b)(6) 2017 - patient visited for mid abdominal pain, small bowel obstruction and ¿balled up mesh¿.(b)(6) 2017 - patient was diagnosed with lower abdominal pain thereby underwent open repair with implant of phasix st mesh (device #4) and removal of all infected mesh (device #1, #2 & #3).Per operative notes, ¿small bowel fistula was seen under mesh and mesh was removed.Lysis of adhesions to colon and bowel was done.A phasix st mesh (device #4) was placed as an underlay and tacked with sutures.Attorney alleges that the patient had abscess, adhesions, bowel removal, fistula, infection, mesh migration, hernia recurrence, pain, wound vac and emotional injuries.
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol composix e/x (device #2) may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.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.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 9 years 10 months post implant of composix mesh e/x, patient was diagnosed with bacterial infection, fistula, obstruction, abscess, adhesions, abdominal pain and mesh deformation thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists fistula & 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 bard/davol composix mesh e/x (device #2).Additional supplemental emdr's were submitted to represent the bard flat mesh (device #1) and bard/davol composix mesh e/x (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.

• Brand Name: COMPOSIX MESH 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: 9287584
• Report Number: 1213643-2019-10728
• Device Sequence Number: 150931
• Product Code: FTL
• UDI-Device Identifier: 00801741031205
• UDI-Public: (01)00801741031205(17)100828(10)43HPD305
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 08/28/2010
• Device Catalogue Number: 0123790
• Device Lot Number: 43HPD305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 03/26/2025
• 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; Disability
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 78 KG