MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRIO ST; SURGICAL MESH

Catalog Number	5950060
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Fistula (1862); Necrosis (1971); Injury (2348)
Date of Event	04/17/2019
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.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 an unspecified bard/davol ventralight st on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the 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 an unspecified bard/davol ventralight st on (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against the 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) 2017 - patient was diagnosed with large incisional hernia thereby underwent open repair with implant of ventrio st.Per op notes, ¿the hernia sac was identified, reduced and excised.Adhesions were lysed.A ventrio st was placed and sutured.¿ (b)(6) 2019 - patient was diagnosed with intrabdominal abscess collection thereby underwent open repair with drainage of abscess.Per op notes,¿ the abdominal wall abscess was identified and drained.¿ (b)(6) 2019 - patient was diagnosed with intrabdominal fluid collection thereby underwent open repair with drainage of fluid.Per op notes, ¿the anterior abdominal wall mesh was identified with fluid and drained.¿ (b)(6) 2019 - patient was diagnosed with infected mesh, pelvic abscess and small bowel fistula thereby underwent open repair with partial excision of ventrio st.Per op notes, ¿the small bowel was adherent to the abdominal wall was taken down.The mesh appeared to be yellow that central part was removed.Upon removing of mesh, a loop of small bowel and abscess was identified.Abscess was drained.The small bowel fistula was identified and removed.A drain was placed.¿ (b)(6) 2019 - patient was diagnosed with infected mesh and small bowel fistula thereby underwent open repair with excision of ventrio st.Per op notes, ¿the small bowel with abscess was identified and drained.The prior mesh appeared to be loose and pulled away.The mesh was excised.The location of the fistula was identified and removed.The fascial edges and soft tissues were necrotic.An enterostomy tube was placed and sutured.¿.
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 the date of implant, brand name and 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-apr-2017) is considered to be a best estimate.Updated fields: a2, a4, b3, b4, b5, b6, b7, d4 (product catalog no., corporate lot no., udi no., expiry date), d6.B (date of explant), g3, g6, h2, h4, h6, h10, h11.Corrected field: d.6a(date of implant), 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: VENTRIO ST
• 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: 9710965
• Report Number: 1213643-2020-01260
• Device Sequence Number: 14258234
• Product Code: FTL
• UDI-Device Identifier: 00801741031557
• UDI-Public: (01)00801741031557(17)190528(10)HUBR1496
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K101920
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 07/16/2025

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: 05/28/2019
• Device Catalogue Number: 5950060
• Device Lot Number: HUBR1496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2017
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 86 KG