MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX AB; SURGICAL MESH

Catalog Number	1151015
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Disability (2371)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges 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; however, no additional details have been provided.Review of manufacturing records indicate product was manufactured to specification.This emdr represents the bard/davol xenmatrix ab (device #3).Additional emdrs were submitted to represent the bard/davol mesh - composix (device #1) and the bard/davol mesh - composix (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) 2004 the patient underwent surgery for repair of an incisional hernia.A bard composix was implanted to repair the hernia defect.On or about (b)(6) 2004 the patient underwent an additional surgery for repair of a recurrent incisional hernia.The surgeon took down the adhesions that were encountered.A bard composix was implanted to repair the recurrent hernia defect.On or about (b)(6) 2008, patient underwent surgery to remove the composix and repair the recurrent incisional hernia.Additionally, during this surgery, the surgeon took down the adhesions and excised the mesh.Then, a non-bard/davol mesh was implanted to attempt to repair the recurrent hernia defect.On or about (b)(6) 2018, patient underwent additional surgery to remove the previously placed mesh and repair recurrent hernias.After entering the abdomen, the surgeon found extensive bowel adhesions to the mesh, which caused a partial bowel obstruction.After extensively lysing the bowel adhesions, the surgeon had to perform two bowel resections and anastomoses.The mesh was then explanted with dense scar tissue and adhesions.The surgeon placed a bard xenmatrix ab in an attempt to repair the abdominal hernia defect.Attorney alleges "past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient".It is also alleged that the patient experienced emotional distress and the device was defective.

• Brand Name: XENMATRIX AB
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10098474
• Report Number: 1213643-2020-05164
• Device Sequence Number: 3448761
• Product Code: PIJ
• UDI-Device Identifier: 00801741074226
• UDI-Public: (01)00801741074226
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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: 01/28/2020
• Device Catalogue Number: 1151015
• Device Lot Number: HUCN0749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 05/28/2020
• 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: Disability