MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number	5955113
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240); Injury (2348)
Date of Event	04/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention; 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 mesh (device #2).An additional emdr was submitted to represent the bard/davol mesh ¿ ventralex (device #1).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 implant of unspecified bard/davol ventralex hernia patch and ventralight st on (b)(6) 2015 and/or (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.Attorney also alleges 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 surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct brand name and pma/510(k) # 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-2014) is considered to be a best estimate.This supplemental emdr represents the bard/davol ventralight st w/echo mesh (device #1).An additional supplemental emdr was submitted to represent the bard/davol mesh ¿ ventralex 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 implant of unspecified bard/davol ventralex hernia patch and ventralight st on (b)(6) 2015 and/or (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.Attorney also alleges that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2015 ¿ patient was diagnosed with incisional hernia and pain thereby underwent laparoscopic repair with implant of ventralight st using echo ps (device #1).Per operative notes, ¿the large epigastric hernia and two small hernias were noted.Adhesions were removed.The large defect was dissected and ventralight st using echo ps (device #1) was placed into the peritoneal cavity sutured and tacked.¿ (b)(6) 2017 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with removal of previously placed mesh (device #1) and implant of phasix flat mesh (device #2).Per operative notes, ¿ adhesions were removed.To the previous midline incision, previously placed mesh (device #1) with scar was noted and excised.The midline fascia was closed with sutures and phasix flat mesh (device #2) was placed in the abdominal wall tacked and sutured.(b)(6) 2017 ¿ patient was diagnosed with umbilical hernia thereby underwent open repair with implant of ventralex st mesh (device #3).Per operative notes, ¿ in the umbilical stalk, hernia defect was dissected.The defect was closed with sutures and ventralex st mesh (device #3) was placed over the defect and sutured.¿ (note: the mesh (device #2) was not visualised during this procedure.) (b)(6) 2019 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of phasix flat mesh (device #4).Per operative notes, ¿ the hernia sac with scar was noted and dissected.A phasix flat mesh (device #4) was placed into the abdominal defect and secured in place with sutures.¿ (note: the mesh (device #2) was not visualised during this procedure.).

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: 9797746
• Report Number: 1213643-2020-02121
• Device Sequence Number: 13605653
• Product Code: FTL
• UDI-Device Identifier: 00801741031694
• UDI-Public: (01)00801741031694(17)160828(10)HUYG1594
• 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: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 08/28/2016
• Device Catalogue Number: 5955113
• Device Lot Number: HUYG1594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2014
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 118 KG