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

Catalog Number	0134810
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Injury (2348); Obstruction/Occlusion (2422)
Date of Event	02/06/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries and subsequent surgery; 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 the patient underwent surgery for implant of an unspecified bard/davol composix l/p on (b)(6) 2009.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device(s).As reported, the patient is making a claim for an adverse patient outcome against the bard/davol composix l/p.As reported, the attorney alleges patient experienced emotional distress and the device was defective.

• Brand Name: Mesh - Composix L/P
• 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: 8795874
• Report Number: 1213643-2019-06127
• Device Sequence Number: 15796632
• Product Code: FTL
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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 Expiration Date: 05/28/2013
• Device Catalogue Number: 0134810
• Device Lot Number: HUSC1973
• 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: 07/01/2019
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2008
• 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