MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number	5992025
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Granuloma (1876); Unspecified Infection (1930); Sepsis (2067); Hernia (2240); Insufficient Information (4580)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol ventralight st and phasix st on (b)(6) 2020 and/or (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against ventralight st.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol ventralight st and phasix st on (b)(6) 2020 and/or (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against ventralight st.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2020 - patient was diagnosed with parastomal hernia with obstruction, incisional hernia with multiple fascial defects with obstruction, known hostile abdomen thereby underwent robotic assisted repair with the implant of ventralight st w/ echo 2 mesh (device #1).Per operative notes, ¿the hernia sac was dissected.A ventralight st w/ echo 2 mesh (device #1) placed and secure it with suture.¿ (b)(6) 2020 - patient was diagnosed with pneumoperitoneum secondary to very small enterotomy without significant intraperitoneal contamination, acute hypoxemic contamination, sever sepsis thereby underwent laparoscopic repair of enterotomy, intraperitoneal drain placement.(b)(6) 2020 - patient was diagnosed with infected abdominal wall mesh, incisional hernia, parastomal hernia, fistula, granuloma, adhesions thereby underwent open repair with explant of ventralight st w/ echo 2 mesh (device #1) and implant of phasix st mesh (device #2).Per operative notes, ¿hernia sac was dissected.Infected ventralight st w/ echo 2 mesh (device #1) was removed.Fistula, adhesions were taken down.A phasix st mesh (device #2) was placed and secure it with suture.¿ (b)(6) 2021 - patient was diagnosed with infected abdominal wall mesh, adhesions, parastomal hernia, incisional hernia, inflammation thereby underwent open repair with explant of phasix st mesh (device #2).Per operative notes, ¿hernia sac was dissected.Infected phasix st mesh (device #2) was removed.Adhesions were taken down.The defect was closed with suture.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; 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.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the 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-feb-2019) is considered to be a best estimate.Updated fields: a2, b3, b4, b5, b6, b7, d4 (product catalog no., corporate lot no, expiry date, udi no.), d6a (date of implant), d6b (date of explant), g3, g6, h2, h4, h6, h10, h11.Corrected field: d1 (brand name), g4 (pma/510(k) #) 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.H3 other text : not returned.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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: 11895293
• Report Number: 1213643-2021-03927
• Device Sequence Number: 14360786
• Product Code: FTL
• UDI-Device Identifier: 00801741131042
• UDI-Public: (01)00801741131042(17)200328(10)HUDP1026
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: 03/28/2020
• Device Catalogue Number: 5992025
• Device Lot Number: HUDP1026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2019
• 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; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male