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

Catalog Number	5955810
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Hernia (2240); Insufficient Information (4580)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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 an unspecified bard/davol ventralight st on (b)(6) 2016.As reported, the patient is making a claim for an adverse patient outcome against ventralight st.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
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: 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-nov-2015) is considered to be a best estimate.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 an unspecified bard/davol ventralight st on (b)(6) 2016.As reported, the patient is making a claim for an adverse patient outcome against ventralight st.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) 2016 - patient was diagnosed with recurrent large ventral incisional hernia thereby underwent laparoscopic repair with implant of ventralight st using echo ps.Per op notes, ¿a large hernia defect was identified and reduced.The small bowel was adherent to abdominal wall was taken down.Adhesions were taken down.A ventralight st using echo ps was placed, sutured and tacked.¿ (b)(6) 2018 - patient was diagnosed with adhesions, recurrent incisional hernia with abdominal pain thereby underwent laparoscopic repair with lysis of adhesions.Per op notes, ¿the omentum stuck to the abdominal wall was taken down.The adhesions of abdominal wall were lysed.The prior mesh was densely adherent to omentum and small bowel was taken down.The mesh was bowing out into the hernia defect.The defect was repaired with sutures.¿ (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia and adhesions thereby underwent open repair with partial excision of ventralight st using echo ps.Per op notes, ¿dense adhesions of abdominal wall to omentum were taken down.The prior mesh was identified and noted with large amount of adhesions to omentum and small bowel was taken down.The necrotic omentum was excised, and the bowed mesh was partially excised.The defect was repaired with sutures.¿ (b)(6) 2019 - patient was diagnosed with recurrent incisional hernia with abdominal pain and infected mesh thereby underwent open repair with excision of ventralight st using echo ps.Per op notes, ¿the hernia sac was identified, dissected free and excised.The adhesions of abdominal wall, small bowel and mesh were taken down.The pus and necrotic tissue around the mesh was excised.Dense intraabdominal adhesions were lysed.The infected mesh was excised entirely.The hernia defect was repaired using sutures.¿.

• 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: 12157082
• Report Number: 1213643-2021-06047
• Device Sequence Number: 3966455
• Product Code: FTL
• UDI-Device Identifier: 00801741031786
• UDI-Public: (01)00801741031786(17)171128(10)HUZK0212
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 11/28/2017
• Device Catalogue Number: 5955810
• Device Lot Number: HUZK0212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2015
• 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: 51 YR
• Patient Sex: Female