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

Catalog Number	0123113
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	04/01/2011
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.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges the patient underwent surgery for implant of an unspecified bard / davol composix e/x on (b)(6) 2007.As reported, the patient is making a claim for an adverse patient outcome against the 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
At this time no conclusions can be made.No lot number has been provided therefore a review of the manufacturing records is not possible.Information is limited at this time.Should additional information be provided a supplemental emdr will be submitted.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the brand name and 510(k).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.Corrected field: d1 (brand name) and g4 (510(k)).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 the patient underwent surgery for implant of an unspecified bard/davol composix e/x on (b)(6) 2007.As reported, the patient is making a claim for an adverse patient outcome against the 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 information provided: (b)(6) 2006 - patient was diagnosed with large ventral incisional hernia, upper midline extending to the right thereby underwent open repair with the implant of composix e/x mesh (device #1).Per operative notes, "adhesions were divided freed up the entire abdominal lining.Multiple large ventral incisional hernias were identified starting at the umbilicus.Three specific hernia defects were identified.The mesh was placed into the abdominal cavity on the hernia defects and tacked." (b)(6) 2011 - patient was diagnosed with small bowel obstruction with massive adhesions thereby underwent laparoscopic repair with the implant of synthetic mesh and removal of bowel.Per operative notes, "the corner and edges of the mesh (device #1) was turned around and adherent.The bowel had grown into it.Lysis of adhesions was performed." (b)(6) 2011 - patient was diagnosed with chronic cholecystitis and cholesterolosis thereby underwent cholecystectomy, open liver biopsy and removal of prior placed synthetic mesh.(b)(6) 2014 - patient was diagnosed with recurrent midline incisional hernia thereby underwent open repair with the implant of phasix mesh.Per operative notes, "the hernia was repaired by imbricating the anterior rectus fascia over the hernia defect in the midline with sutures.A piece of phasix mesh (device #2) was laid over the top of the repair and sutured.".

• 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: 8957537
• Report Number: 1213643-2019-08234
• Device Sequence Number: 2151090
• Product Code: FTL
• UDI-Device Identifier: 00801741031168
• UDI-Public: (01)00801741031168(10)43CQD382
• 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: 2006
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: 0123113
• Device Lot Number: 43CQD382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 07/07/2025
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 134 KG