MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 COMPOSIX MESH 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	Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Injury (2348)
Date of Event	11/12/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; 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 an unspecified bard/davol composix on (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the composix.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct brand name pma/50(k)#.Root cause is in-conclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-apr-2013) is considered to be a best estimate.Updated fields: a2, b3, b4, b5, b7, d3, d4, d.6b (date of explant), g1, g3, g4, g6, h2, h4, h6, h10, h11.Corrected fields: d1 (brand name), g4 (pma/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 that the patient underwent surgery for implant of an unspecified bard/davol composix on (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the composix.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2013 ¿ patient had anterior wall defect thereby underwent laparoscopic repair with the implant of composix e/x mesh.Per operative notes, ¿the composix e/x mesh was placed against anterior abdominal wall using tacks.¿ (b)(6) 2013 ¿ patient had abdominal pain, abdominopelvic mass thereby underwent laparoscopic dissection of abdominopelvic mass, lysis of pelvic and abdominal adhesion, dilation and curettage.(b)(6) 2013 ¿ patient was diagnosed with infected lower abdominal mesh thereby underwent open repair with the removal of mesh.Per operative notes, ¿the mesh was completely dissected off and biological mesh placed to rectus sheath using sutures.¿.

• 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: 11326707
• Report Number: 1213643-2021-01035
• Device Sequence Number: 16789588
• Product Code: FTL
• UDI-Device Identifier: 00801741031199
• UDI-Public: (01)00801741031199(17)180428(10)HUXD0196
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 04/28/2018
• Device Catalogue Number: 0123680
• Device Lot Number: HUXD0196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2013
• 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
• Patient Age: 29 YR
• Patient Sex: Female