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

Catalog Number	5955113
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, pain and suffering and permanent injury, however, no details have been provided.No manufacturing issues associated to the reported event as described were found in the reviewed lot.Dhr review showed component acceptability and traceability were confirmed through incoming inspection records for traceable components used.All process steps were completed per manufacturing procedures, inspection procedures, as documented in work order and lot history records.Product passed all required inspections at both end product and subassembly levels.The instructions for use (ifu) included with this product prescribed the proper method of implantation for this device to prevent undue injury to the patient and damage to the product.Ifu states the device is supplied sterile and the package must be inspected for damage prior to use.Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for repair of ventral incisional hernia with a non bard/ davol proceed mesh on or about (b)(6) 2009.On or about (b)(6) 2010, the patient underwent a surgical mesh removal and repair of a recurrence of the hernia defect.It is also alleged by the patient's attorney that on or about (b)(6) 2012, the patient underwent a repair of a recurrence of the hernia defect and a bard ventralight st mesh with echo ps positioning system, reference number 5955113, lot number huwc0648 was implanted on the same day.As alleged, the patient has suffered and will continue to suffer physical pain and suffering, as well as mental anguish, emotional distress, injury, anxiety, depression, disability and the device was defective.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9516525
• Report Number: 1213643-2019-12498
• Device Sequence Number: 1883460
• Product Code: FTL
• UDI-Device Identifier: 00801741031694
• UDI-Public: (01)00801741031694
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/24/2019

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: 03/31/2013
• Device Catalogue Number: 5955113
• Device Lot Number: HUWC0648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 12/24/2019
• 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