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	Adhesion(s) (1695); Injury (2348); Disability (2371)
Date of Event	05/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Currently, it is unknown to what extent the ventralight st w/ echo (device #2) device may have caused or contributed to the reported event.To date no medical records have been provided.The information provided alleges that the patient underwent an exploratory laparotomy procedure.Upon entering the patient's abdomen the physician noted that he performed extensive lysis of adhesions and freed the small bowel off of the mesh.Adhesion is a known inherent risk of surgery and is listed in the instructions-for-use as a possible complication.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.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol ventralight st w/ echo (device #2).An additional emdr was submitted to represent the bard/davol ventralight st w/ echo (device #1).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: on (b)(6) 2015: the patient underwent laparoscopic repair of an incarcerated ventral hernia.A ventralight st w/echo (device #1) and/or a ventralight st w/echo (device #2) was implanted in the patient during this repair.On (b)(6) 2016: the patient underwent an exploratory laparotomy procedure.Upon entering the patient's abdomen.The physician noted that he performed an extensive lysis of adhesions and freed the small bowel off of the mesh.The attorney alleges prior to and after this procedure, patient suffered severe and debilitating pain.Patient also requires further medical treatment, including likely need for future surgeries.The ventralight st w/ echo (device #1 and/or device #2) implanted in the patient failed to reasonably perform as intended.The patient's attorney alleges general allegations for past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by patient, permanent impairment, mental pain and suffering.

• 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: 7803235
• Report Number: 1213643-2018-02849
• Device Sequence Number: 19455092
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2018

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: 08/28/2016
• Device Catalogue Number: 5955113
• Device Lot Number: HUYG1595
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/21/2018
• 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