MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Mesh - Composix E/X; Surgical Mesh

Catalog Number	0123810
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Hematoma (1884); Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	06/30/2010
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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix mesh on (b)(6) 2010.As reported, the patient is making a claim for an adverse patient outcome against the composix mesh.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is alleged that the patient sustained personal injury, experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol composix mesh on (b)(6)2010.As reported, the patient is making a claim for an adverse patient outcome against the composix mesh.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is alleged that the patient sustained personal injury, experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6)2010- patient was diagnosed with incarcerated ventral hernia thereby underwent repair with implant of composix e/x mesh.(b)(6)2010- patient was diagnosed with infected mesh, small hematoma, small abscess, thereby underwent laparoscopic repair with explant of composix e/x mesh, implant of unknow mesh.Per op notes, ¿through midline incision, composix kugel mesh was noted and was found adherent to the tissue.There was a small pocket of hematoma.A small piece of unknown mesh was placed and small abscess just below the umbilicus was noted¿.(b)(6)2010- patient was diagnosed with open abdominal wound.(b)(6)2010- patient had skin closure over previously closed fascia of open abdominal wound.(b)(6)2021- patient was diagnosed with ventral incisional hernia, thereby underwent open repair with implant of synthetic mesh.
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 the sex, brand name and pma/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.Updated fields: a2, b3, b4, b5, b6, b7, d3, d4 (product lot no., product catalog no., udi no), d.6b (date of explant), g3, g6, h2, h6, h10, h11.Corrected field: a3 (sex), 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.

• 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 ; +1(401)825-8495
• MDR Report Key: 12785285
• Report Number: 1213643-2021-08523
• Device Sequence Number: 3874311
• Product Code: FTL
• UDI-Device Identifier: 00801741031212
• UDI-Public: (01)00801741031212(10)43IQD319
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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: 0123810
• Device Lot Number: 43IQD319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 08/25/2026
• 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
• Patient Sex: Male