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

Catalog Number	5954124
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	04/28/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no connection that can be made at this time between the reported post-operative complications and the bard/davol ventralight st device used to treat the patient.As alleged by the patient's attorney "there was a loop of small bowel that was adherent to the corner of the mesh"; adhesions are a known inherent risk of surgery and are listed in the instructions-for-use as a possible complication.The patient's attorney did not allege a specific device failure and no medical records have been provided to date.A sample was not provided for further evaluation.Based on the limited information provided at this time, no conclusions can be made between the bard/davol ventralight st device used to treat the patient and any problem with the device.Should additional information be provided, a supplemental emdr will be submitted.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: (b)(6) 2015 - patient underwent an incisional hernia repair a bard/davol "ventralight st bard mesh" was implanted in the patient during this repair.(b)(6) 2015 - patient underwent release of a small-bowel obstruction and removal of the failed ventralight st.Upon exploration of the patient's abdomen, the doctor noted "there was a loop of small bowel that was adherent to the corner of the mesh in the right lateral abdominal wall.The abdominal mesh was entirely removed." as reported the patient's attorney alleges that the ventralight st "had to be removed via invasive surgery and necessitated additional invasive surgery to repair the hernia" and that "the patient has been injured and sustained severe pain and suffering, disability and impairment.".

• Brand Name: VENTRALIGHT ST MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7526592
• Report Number: 1213643-2018-01589
• Device Sequence Number: 13759155
• Product Code: FTL
• UDI-Device Identifier: 00801741031601
• UDI-Public: (01)00801741031601
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

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: 06/28/2015
• Device Catalogue Number: 5954124
• Device Lot Number: HUXF0497
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/18/2018
• 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