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

Catalog Number	5955610
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Disability (2371)
Date of Event	05/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol ventralight st w/ echo (device #1) device may have caused or contributed to the reported events.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.This emdr represents the bard/davol ventralight st w/ echo (device #1).An additional emdr was submitted to represent the bard/davol bard flat mesh (device #2).Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2017: the patient underwent an epigastric hernia repair.A bard ventralight st (device #1) was implanted during this repair.On (b)(6) 2017: the patient was hospitalized for complications.On (b)(6) 2008: the patient underwent colonoscopy removal of (description not provided).On (b)(6) 2018: the patient underwent incision and drainage of superficial abdominal wall abscess.On (b)(6) 2019: the patient underwent an open retrorectus ventral hernia repair further surgery due to complications.The patient was implanted with a bard mesh (device #2).Patient continues to suffer complications, permanent disfigurement and chronic pain.The bard mesh implanted in patient failed to reasonably perform as intended.The bard mesh caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the bard mesh was initially implanted to treat.The patient has sustained and will continue to sustain emotional distress and severe physical injuries.The patient has been injured, sustained severe and permanent pain, suffering, anxiety, depression, disability, and impairment.

• 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: 8828673
• Report Number: 1213643-2019-06360
• Device Sequence Number: 2823818
• Product Code: FTL
• UDI-Device Identifier: 00801741031748
• UDI-Public: (01)00801741031748
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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: 05/28/2018
• Device Catalogue Number: 5955610
• Device Lot Number: HUAQ2115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/25/2019
• 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: Hospitalization; Required Intervention; Disability