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

Catalog Number	5954800
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	03/14/2019
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 details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol ventralight st (device #4).Additional emdrs were submitted to represent the bard/davol ventralex (device #1 & device #2) and the bard/davol ventralight st (device #3).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 the implant of two unspecified bard/davol ventralex on (b)(6) 2009 and two ventralight st on (b)(6) 2013 and (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against all devices.It is alleged that the patient sustained injuries on (b)(6) 2013.Attorney alleges general allegations for "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." it is also alleged that the patient experienced emotional distress and the device was defective.
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 details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-jul-2016) is considered to be a best estimate.This supplemental emdr represents the ventralight st mesh (device #4).An additional supplemental emdr were submitted to represent the bard/davol mesh -ventralex (device #1, #2) and the bard/davol ventralight st (device #3).Note: section a through f - the information provided by bd 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 bd.
Event or Problem Description
Attorney alleges that the patient underwent surgery for the implant of two unspecified bard/davol ventralex on (b)(6) 2009 and two ventralight st on (b)(6) 2013 and (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against all devices.It is alleged that the patient sustained injuries on (b)(6) 2013.Attorney alleges general allegations for "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." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2009 ¿ patient was diagnosed with incisional hernia and umbilical hernia thereby underwent open repair with implant of two ventralex mesh (device #1 and #2).Per operative notes, ¿ upper midline incisional hernia sac was noted.And medium ventralex mesh (device #1) was placed into the defect and tacked and sutured.In umbilical hernia, the sac was dissected and small ventralex mesh (device #2) was placed over the defect and tacked and sutured.¿ (b)(6) 2013 - patient was diagnosed with recurrent umbilical incisional hernia thereby underwent laparoscopic repair with implant of ventralight st mesh (device #3).Per operative notes, ¿ adhesions of omentum to mesh (device #2) were removed.To the defect the ventralight st mesh (device #3) was chosen for repair and sutured and tacked.¿ (b)(6) 2015 ¿ patient had recurrence at epigastric site thereby underwent open repair.(b)(6) 2017 - patient was diagnosed with recurrent epigastric ventral hernia thereby underwent laparoscopic repair with implant of ventralight st mesh (device #4).Per operative notes, ¿ the mesh in the lower abdomen (device#2 and #3) was noted along with adhesions.The upper abdomen mesh (device #1) was seen shrunken up in the defect and ventralight st mesh (device #4) was placed and sutured.¿ (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of ventralex st mesh (device #5).Per operative notes, ¿ the hernia was noted and reduced.A medium size ventralex st mesh (device #5) was placed , sutured and stapled.¿.

• 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
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 9792568
• Report Number: 1213643-2020-02090
• Device Sequence Number: 11406568
• Product Code: FTL
• UDI-Device Identifier: 00801741031670
• UDI-Public: (01)00801741031670(17)180728(10)HUAU1877
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 07/28/2018
• Device Catalogue Number: 5954800
• Device Lot Number: HUAU1877
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female