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

Catalog Number	0123680
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Disability (2371)
Date of Event	03/27/2012
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 including permanent injury, recurrence, adhesions, inflammation and subsequent surgical intervention.The instructions-for-use supplied with the device lists recurrence, adhesions, and inflammation as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the bard/davol composix mesh e/x (device #1).An additional emdr was submitted to represent the bard flat mesh (device #2).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that, on or about (b)(6) 2011, the patient underwent repair of a lower midline hernia and was implanted with composix ex mesh.On or about (b)(6) 2012, the patient underwent revision of the composix e/x and a non-bard/davol mesh was implanted.On or about (b)(6) 2012, the patient underwent revision of the composix e/x and non bard/davol mesh and then was implanted with 6 x 6 in.Marlex mesh (bard flat mesh).On or about (b)(6) 2014, the patient underwent removal of composix e/x, bard marlex mesh (bard flat mesh) and non bard/davol mesh.It is alleged that the patient experienced and/or continues to experience severe and chronic pain, inflammation, eventration of the mesh, pelvic mass, necrosis, scarring, adhesions to small intestine and bowel, and surgery to remove the meshes.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." it is also alleged that the device was defective.

• Brand Name: COMPOSIX MESH 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: 11381205
• Report Number: 1213643-2021-01313
• Device Sequence Number: 4010570
• Product Code: FTL
• UDI-Device Identifier: 00801741031199
• UDI-Public: (01)00801741031199
• 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: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: 08/28/2012
• Device Catalogue Number: 0123680
• Device Lot Number: HURG1016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/25/2021
• 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