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

Catalog Number	0123113
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Disability (2371)
Date of Event	04/08/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown to what extent the bard/davol composix e/x device may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges the patient underwent an additional surgery to explant a composix e/x during which it is alleged that the surgeon noted adhesions, recurrence, and curling of the mesh; however, no sample has been provided for evaluation and no medical records are available.Recurrence and adhesions are known inherent risks of hernia repair surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complication.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental emdr will be submitted.Note: the information provided by bard 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 bard.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: on (b)(6) 2006: the patient underwent repair of multiple ventral hernias.As reported, a composix e/x 10" x 13", ref no.0123113, lot no.43cpd488 was implanted in the patient during this repair.On (b)(6) 2013: the patient underwent surgery to explant a failed composix e/x.As reported, during the surgery, the surgeon noted that "approximately 80% of previous composix mesh was adherent omentum, small bowel.There were recurrent hernia superiorly, inferiorly, and to the right lateral aspect of the previous repair.The mesh had curled, and there was exposed polypropylene mesh, with additional adhesions of small bowel and colon to the area." it is alleged that the patient continues to experience complications related to the eptfe bard mesh (composix ex) and will likely require additional surgeries to repair the damage from the allegedly "defective" composix ex mesh.

• Brand Name: COMPOSIX E/X
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7506190
• Report Number: 1213643-2018-01415
• Device Sequence Number: 1529151
• Product Code: FTL
• UDI-Device Identifier: 00801741031168
• UDI-Public: (01)00801741031168
• Combination Product (Y/N): N
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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: 03/28/2010
• Device Catalogue Number: 0123113
• Device Lot Number: 43CPD488
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability